Medical device for modification of left atrial appendage and related systems and methods

ABSTRACT

Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an occluder portion and an anchor portion. The occluder portion includes a hub that defines an axis, the occluder portion extending between a proximal end coupled to the hub and a distal end defining an occluder eyelet adjacent thereto. The anchor portion extends between a first end and a second end, the first end coupled to an anchor hub and the second end defining an anchor eyelet adjacent thereto and hingeably coupled to the occluder eyelet. With this arrangement, the anchor hub is moveable along the axis to move the anchor portion between a retracted position and a deployed position upon the occluder portion being in an expanded position.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 15/094,254, filed Apr. 8, 2016, which claims thebenefit of U.S. Provisional No. 62/148,317, filed on Apr. 16, 2015.Further, U.S. patent application Ser. No. 15/094,254 also claims benefitto, and is a continuation-in-part of, U.S. patent application Ser. No.14/308,695, filed Jun. 18, 2014, which in turn claims benefit to U.S.Provisional Application No. 61/837,628, filed on Jun. 20, 2013. Further,U.S. patent application Ser. No. 14/308,695 claims benefit to, and is acontinuation-in-part of, U.S. patent application Ser. No. 13/666,612,filed Nov. 1, 2012, which in turn claims benefit to U.S. ProvisionalApplication No. 61/553,948, filed on Nov. 1, 2011, and U.S. ProvisionalApplication No. 61/661,799, filed on Jun. 19, 2012. Further, theabove-listed U.S. patent application Ser. No. 13/666,612 claims benefitto, and is a continuation-in-part of, U.S. patent application Ser. No.12/818,046, filed on Jun. 17, 2010, now issued as U.S. Pat. No.8,636,764, which in turn claims benefit to the following U.S.Provisional patent applications: U.S. Provisional Application No.61/345,514, filed on May 17, 2010; U.S. Provisional Application No.61/325,230, filed on Apr. 16, 2010; U.S. Provisional Application No.61/320,635, filed on Apr. 2, 2010; U.S. Provisional Application No.61/294,058, filed on Jan. 11, 2010; and U.S. Provisional Application No.61/218,018, filed on Jun. 17, 2009. The disclosures of each applicationlisted above are incorporated by reference herein in their entireties.

TECHNICAL FIELD

The present invention relates generally to the occlusion or modificationof tissue openings or appendages and, more specifically, to devices,systems and methods for occluding or otherwise structurally alteringsuch openings and appendages including, for example, left atrialappendages.

BACKGROUND

The upper chambers of the heart, the atria, have appendages attached toeach of them. For example, the left atrial appendage is a feature of allhuman hearts. The physiologic function of such appendages is notcompletely understood, but they do act as a filling reservoir during thenormal pumping of the heart. The appendages typically protrude from theatria and cover an external portion of the atria. Atrial appendagesdiffer substantially from one to another. For example, one atrialappendage may be configured as a tapered protrusion while another atrialappendage may be configured as a re-entrant, sock-like hole. The innersurface of an appendage is conventionally trabeculated with cords ofmuscular cardiac tissue traversing its surface with one or multiplelobes.

The atrial appendages appear to be inert while blood is being pumpedthrough them during normal heart function. In other words, theappendages don't appear to have a noticeable effect on blood pumpedthrough them during normal heart function. However, in cases of atrialfibrillation, when the atria go into arrhythmia, blood may pool andthrombose inside of the appendages. Among other things, this can pose astroke risk when it occurs in the left appendage since the thrombus maybe pumped out of the heart and into the cranial circulation once normalsinus rhythm is restored following arrhythmia events.

Historically, appendages have sometimes been modified surgically toreduce the risk imposed by atrial fibrillation. In recent years deviceswhich may be delivered percutaneously into the left atrial appendagehave been introduced. The basic function of these devices is to excludethe volume within the appendage with an implant which then allows bloodwithin the appendage to safely thrombose and then to be graduallyincorporated into cardiac tissue. This process, coupled with the growthof endothelium over the face of the device, can leave a smooth,endothelialized surface where the appendage is located. In comparison tosurgical procedures, devices implanted percutaneously are a lessinvasive means for addressing the problems associated with the leftatrial appendage.

However, due to the wide variability of the ostium size and volume ofthe left atrial appendage, current implantable devices conventionallyinclude a structure that cannot meet such variability, resulting ininadequate devices for many left atrial appendage anatomies. Further,such implantable devices are substantially limited by the orientation bywhich they can successfully be deployed. As such, it would beadvantageous to provide a percutaneous system, method and/or device thataddresses, for example, the issues of implant orientation, thevariability in sizes and shapes of the left atrial appendage, or all ofthese, in order to provide high success in left atrial appendagemodification. It would also be desirable to provide a device, system andmethod that enables easy positioning and repositioning of the devicerelative to the structure being modified or occluded including thepositioning (or repositioning) of an occluder portion independent ofother components or features of the device.

A variety of features and advantages will be apparent to those ofordinary skill in the art upon reading the description of variousembodiments set forth below.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices,systems and methods of occluding an opening in the tissue of a body. Forexample, in one embodiment, a medical device for implantation in a leftatrial appendage of a heart is provided. The medical device includes anoccluder portion and an anchor portion. The occluder portion includes ahub that defines an axis, the occluder portion extending between aproximal end coupled to the hub and a distal end defining an occludereyelet adjacent thereto. The anchor portion extends between a first endand a second end, the first end coupled to an anchor hub and the secondend defining an anchor eyelet adjacent thereto and hingeably coupled tothe occluder eyelet. With this arrangement, the anchor hub is moveablealong the axis to move the anchor portion between a retracted positionand a deployed position upon the occluder portion being in an expandedposition.

In another embodiment, the anchor portion extends with anchor framesegments, the anchor frame segments including anchoring tines extendingtherefrom. In a further embodiment, the anchoring tines extend with anacute angle relative to the anchor frame segments, the acute anglehaving a range between about 25 degrees and about 60 degrees. In still afurther embodiment, the anchoring tines extend with a height relative tothe anchor frame segments, the height having a range between about 0.020inches and about 0.050 inches. In another embodiment, the anchoringtines extending from a single strut are spaced a distance from adjacenttines within a range between about 0.060 inches and 0.015 inches. In yetanother embodiment, the anchor frame segments include anchoring tinesaligned with and extending from struts defining the anchor framesegments, the struts being non-aligned relative to the axis.

In accordance with another embodiment of the present invention, amedical device for implantation in a left atrial appendage of a heart isprovided. In this embodiment, the medical device includes a frameworkhaving a proximal end and a distal end and defining an axis. Theframework extends between a primary hub and a secondary hub, the primaryhub and the secondary hub aligned along the axis of the framework suchthat the proximal end of the framework is coupled to the primary hub.The framework extends radially outward and distally from the primary huband extends radially inward and proximally toward the secondary hub suchthat the secondary hub is positioned proximal the distal end of theframework.

In another embodiment, the framework includes anchoring tines extendingtherefrom. In a further embodiment, the anchoring tines extend with anacute angle relative to struts of the framework, the acute angle havinga range between about 25 degrees and about 60 degrees. In still anotherfurther embodiment, the anchoring tines extend with a height relative tostruts of the framework, the height having a range between about 0.020inches and about 0.050 inches. In another embodiment, the anchoringtines extending from a given strut of the framework are spaced adistance from adjacent tines within a range between about 0.060 inchesand 0.015 inches.

In another embodiment, the framework includes anchoring tines alignedwith and extending from struts of the framework, the struts beingnon-aligned relative to the axis. In another embodiment, the frameworkincludes occluder frame segments and anchor frame segments, the anchorframe segments hingeably coupled to the occluder frame segments. In afurther embodiment, the anchor frame segments are moveable between aretracted position and a deployed position upon the occluder framesegments being in an expanded position.

In another embodiment, the framework includes a tissue growth memberpositioned over at least a proximal side of the framework. In stillanother embodiment, the framework includes a tissue growth memberincluding at least one of a fabric material and ePTFE. In a furtherembodiment, the tissue growth member includes a hydrophilic coating.

In accordance with another embodiment of the present invention, a methodfor occluding a left atrial appendage is provided. The method includesthe step of positioning a framework within the left atrial appendage,the framework having a proximal end and a distal end and defining anaxis, the framework extending between a primary hub and a secondary hub,the primary hub and the secondary hub aligned along the axis of theframework, the proximal end of the framework coupled to the primary hub,the framework extending radially outward and distally from the primaryhub and extending radially inward and proximally toward the secondaryhub such that the secondary hub is positioned proximal the distal end ofthe framework.

In another embodiment, the method further includes the step of securingthe framework to tissue within the left atrial appendage with anchoringtines extending from anchor frame segments of the framework. In anotherembodiment, the method further includes the step of pivoting anchorframe segments of the framework between a retracted position and adeployed position.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparentupon reading the following detailed description and upon reference tothe drawings in which:

FIG. 1 is a perspective view of a medical device and a distal portion ofa delivery system, according to one embodiment of the present invention;

FIG. 1A is a partial cross-sectional view of the medical device, takenalong section line 1A of FIG. 1, according to another embodiment of thepresent invention;

FIG. 1B is an enlarged section view of an occluder portion, taken fromdetail 1B of FIG. 1A, according to another embodiment of the presentinvention;

FIG. 2 is a perspective view of the medical device of FIG. 1, depictingthe frame without its tissue growth member, according to anotherembodiment of the present invention;

FIG. 3 is a top view of frame components of the occluder portion and theanchor portion of the medical device of FIG. 2, depicting framecomponents laser cut from a flat sheet prior to being assembled,according to another embodiment of the present invention;

FIG. 3A is a partial enlarged view of the anchor portion depicted inFIG. 3, according to another embodiment of the present invention;

FIG. 3B is an enlarged view of a hinged coupling between the occluderportion and the anchor portion of the medical device, according toanother embodiment of the present invention;

FIG. 4 is a perspective views of a medical device delivery system,according to another embodiment of the present invention;

FIG. 5 is a side view of an end portion of a delivery catheter,according to another embodiment of the present invention;

FIG. 5A is a cross-sectional view of the end portion of the deliverycatheter, taken along a longitudinal axis of the delivery catheter ofFIG. 5, according to another embodiment of the present invention;

FIG. 5B is an enlarged view of the end portion of the delivery catheter,according to another embodiment of the present invention;

FIGS. 6A-6C are perspective views of a loader, depicting the loaderbeing pushed over an occluder portion of the medical device, the medicaldevice inserted into a sheath, and pushed to a distal end of the sheath,respectively, according to another embodiment of the present invention;

FIG. 7 is a side view of a distal portion of the sheath, depicting aportion of the medical device exposed at a distal end of the sheath inthe LAA, according to another embodiment of the present invention;

FIG. 8 is a cross-sectional side view of the distal portion of thedelivery system and the medical device, depicting a sheath withdrawn todeploy the occluder portion of the medical device in the LAA anddepicting the anchor portion in an anchor non-deployed position,according to another embodiment of the present invention;

FIG. 8A is a side view of a handle, depicting the handle in a firstposition corresponding to the anchor non-deployed position, according toanother embodiment of the present invention;

FIG. 9 is a cross-sectional side view of the distal portion of thedelivery system and the medical device, depicting both the occluderportion and the anchor portion in an anchor deployed position in theLAA, according to another embodiment of the present invention;

FIG. 9A is a side view of the handle, depicting the handle in a secondposition corresponding to the anchor deployed position, according toanother embodiment of the present invention;

FIG. 10 is a cross-sectional side view of the distal portion of thedelivery system and the medical device, depicting the delivery system inthe process of being released from the medical device in the LAA,according to another embodiment of the present invention;

FIG. 10A is a side view of the handle, depicting a portion of the handlebeing rotated for releasing the medical device, according to anembodiment of the present invention;

FIG. 10B is a side view of the handle, depicting a portion of the handleactuated from the second position to the first position, according to anembodiment of the present invention;

FIG. 11 is a cross-sectional side view of the distal portion of thedelivery system and the medical device, depicting the delivery catheterfully released from the medical device, according to another embodimentof the present invention;

FIG. 12 is a partial perspective view of the proximal side of themedical device coupled to the delivery system, according to anotherembodiment of the present invention;

FIGS. 13A and 13B are cross-sectional side views of the handle,depicting a release button in a first and second position, respectively,to facilitate actuation of a plunger shaft, according to anotherembodiment of the present invention;

FIGS. 14A and 14B are simplistic side profile views of anotherembodiment of a medical device, depicting the medical device in ananchor non-deployed position and an anchor deployed position,respectively, according to the present invention;

FIG. 15 is a top view of the occluder portion and the anchor portion ofthe medical device of FIGS. 14A and 14B, depicting fame components cutfrom a flat sheet, according to another embodiment of the presentinvention;

FIGS. 16A and 16B are simplistic side profile views of anotherembodiment of a medical device, depicting the medical device in ananchor non-deployed position and an anchor deployed position,respectively, according to the present invention;

FIG. 17 is a top view of the occluder portion and the anchor portion ofthe medical device of FIGS. 15A and 15B, depicting frame components cutfrom a flat sheet, according to another embodiment of the presentinvention;

FIG. 18 is a perspective view of a medical device delivery system,depicting a medical device attached and deployed at a distal end of thedelivery system, according to another embodiment of the presentinvention;

FIG. 18A is a cross-sectional view of section 18A of FIG. 18, depictinga lumen defined in a proximal portion of a catheter of the deliverysystem, according to another embodiment of the present invention;

FIG. 18B is a cross-sectional view of section 18B of FIG. 18, depictinga sheath lumen of a sheath with the catheter of the delivery systemtherein, according to another embodiment of the present invention;

FIG. 19 is a cross-sectional view of the medical device and the distalportion of the delivery system, depicting a contrast fluid flowing froma hub of the medical device and into the left atrial appendage,according to another embodiment of the present invention;

FIG. 20 is an enlarged cross-sectional view of the distal portion of thedelivery system and the hub of the medical device (with the occluderportion removed for simplification purposes), depicting a flow path ofthe contrast fluid moving through the delivery system and hub of themedical device, according to another embodiment of the presentinvention;

FIG. 20A is an enlarged cross-sectional view taken from region 20A ofFIG. 20, depicting the flow path for the contrast fluid at a distalportion of the delivery system, according to another embodiment of thepresent invention;

FIG. 20B is an enlarged cross-sectional view taken from region 20B ofFIG. 20, depicting the flow path for the contrast fluid at the hub ofthe medical device, according to another embodiment of the presentinvention;

FIG. 21 is a side view of another embodiment of a medical device,according to the present invention;

FIG. 22 is an exploded view of the medical device of FIG. 21, accordingto another embodiment of the present invention;

FIG. 23 is a top view of an occluder frame of an occluder portion,depicting the occluder frame as cut from a flat sheet of material,according to another embodiment of the present invention;

FIG. 24 is a top view of an anchor portion, depicting the anchor frameas cut from a flat sheet of material, according to another embodiment ofthe present invention;

FIG. 25 is a front view of an occluder hub retainer, according toanother embodiment of the present invention;

FIG. 25A is a cross-sectional view taken along section A-A of FIG. 25,according to another embodiment of the present invention;

FIG. 26 is a front view of an occluder hub portion, according to anotherembodiment of the present invention;

FIG. 26A is a cross-sectional view taken along section A-A of FIG. 26,according to another embodiment of the present invention;

FIG. 27 is an enlarged perspective view of an occluder hub, depictingthe occluder frame coupled to the occluder hub, according to anotherembodiment of the present invention;

FIG. 28 is a top view of another embodiment of an anchor portion,depicting the anchor portion as cut from a flat sheet, according to thepresent invention;

FIG. 28A is an enlarged view of a portion of the anchor portion of FIG.28, depicting tines extending from struts of the anchor portion,according to another embodiment of the present invention;

FIG. 29 is an enlarged view of another embodiment of tines extendingfrom struts of an anchor portion, according to the present invention;

FIG. 30 is an enlarged view of another embodiment of tines extendingfrom struts of an anchor portion, according to the present invention;

FIG. 31 is an enlarged view of another embodiment of tines extendingfrom struts of an anchor portion, according to the present invention;

FIG. 32 is an enlarged view of another embodiment of tines extendingfrom struts of an anchor portion, according to the present invention;

FIG. 33 is an enlarged view of another embodiment of tines extendingfrom struts of an anchor portion, according to the present invention;

FIG. 34 is an enlarged view of another embodiment of tines extendingfrom struts of an anchor portion, according to the present invention;

FIG. 35 is a top view of another embodiment of an anchor portion,depicting the anchor portion extending in a radial pattern, according tothe present invention;

FIG. 36 is an exploded view of a medical device, according to anotherembodiment of the present invention;

FIG. 37 is a side view of the assembled medical device of FIG. 36,according to another embodiment of the present invention; and

FIG. 37A is an enlarged cross-sectional view of an occluder portion,depicting layers of an occluder material positioned over the occluderframe portion, according to another embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring first to FIGS. 1 and 1A, a medical device 20 and a distal endportion of a delivery system 22 is provided. The medical device 20 anddelivery system 22 may be employed in interventional procedures forpercutaneously closing and modifying an opening or cavity such as, forexample, a left atrial appendage (“LAA”) within a heart (not shown). Themedical device 20 may include frame components of an occluder portion 24and an anchor portion 26, the occluder portion 24 also including atissue growth member 28 attached thereto. Further, the anchor portion 26may be hingably coupled to the occluder portion 24 such that the anchorportion 26 may be actuated, upon deployment of the occluder portion 24,between a deployed position and a non-deployed position (not shown) viaan actuation mechanism at a handle (not shown) of the delivery system22. With this arrangement, the medical device 20 and delivery system 22may provide functionality of separating the steps of deploying theoccluder portion 24 and the anchor portion 26, thereby, providingadditional and enhanced functionality to the physician to properlyposition and implant the medical device 20 in the LAA.

As set forth, the occluder portion 24 may include an occluder materialor a tissue growth member 28 attached thereto. The tissue growth member28 may be a porous material, or other cell attaching material orsubstrate, configured to promote endothelization and tissue growththereover. The tissue growth member 28 may extend over a proximal sideof the medical device 20 and, particularly, over the occluder portion 24and may extend over a portion of the anchor portion 26 and hingescoupling the anchor portion 26 to the occluder portion 24. As such, dueto the shape of the frame components of the occluder portion 24, thetissue growth member 28 may include a proximal face that is generallyconvex to form an outer surface 40. The tissue growth member 28 may alsoinclude an inner surface 42 on its distal side that is generally concaveshaped. In one embodiment, the tissue growth member 28 may extendprimarily over an outside surface of frame components of the occluderportion 24 with a portion of the tissue growth member 28 extending onboth the outside surface and the inside surface of the frame componentsof the occluder portion 24. In another embodiment, the tissue growthmember 28 may extend primarily over both the outside surface and theinside surface of the frame components of the occluder portion 24 of themedical device 20. In another embodiment, the tissue growth member 28may extend solely over the outside surface of the frame components ofthe occluder portion 24.

With respect to FIGS. 1A and 1B, the tissue growth member 28 may includeone or more types of materials and/or layers. In one embodiment, thetissue growth member 28 may include a first material layer 30 and asecond material layer 32. The first material layer 30 may primarily bean underside layer or base layer of the tissue growth member 28. Thefirst material layer 30 may include porous and conformable structuralcharacteristics. For example, the first material layer 30 may include afoam type material, such as, a polyurethane foam or any other suitablepolymeric material, such as a polymer fabric, woven or knitted. Thesecond material layer 32 may include one or more layers of, for example,an expanded polytetrafluoroethylene (ePTFE) material. The secondmaterial layer 32 may be attached to an outer surface of the firstmaterial layer 30 with, for example, an adhesive. In one embodiment, thesecond material layer 32 may include a first layer 32A, a second layer32B, and a third layer 32C such that the first layer 32A may be directlyattached to the first material layer 30 and the third layer 32C may bean outer-most layer covering the proximal side of the medial device 20with the second layer 32B extending therebetween. The various layers ofthe second material layer 32 may be bonded together by adhesives and/orby a thermal bonding heat process or other appropriate processes knownin the art. In one particular example, the outer-most layers, such asthe second and third layers 32B, 32C, may be formed of an ePTFE materialhaving an internodal distance (sometimes referred to as pore size) ofapproximately 70 μm to approximately 90 μm. The first layer 32A of thesecond material layer 32, adjacent the first material layer 30, may beformed of an ePTFE material having a reduced internodal distancerelative to the second and third layers 32B, 32C. For example, theinternodal distance of the first layer 32A may be approximately 10 μm.This first layer 32A may be bonded or adhered to the first materiallayer 30 using an adhesive material. Any other suitable sized layers ofePTFE may be employed, such as ePTFE having an internodal distance up toabout 250 μm. Further, there may be one or more additional layers,similarly sized to the first layer 32A, extending over a hub end 34 withflaps 36 (outlined with an “X” configuration) where the delivery system22 interconnects with the medical device 20 (see FIG. 1).

The second material layer 32 made of ePTFE effectively prevents thepassage of blood, due to the small internodal distance and pore size ofthe first layer 32A, while the larger internodal distance of otherlayers (e.g., 32B and 32C) enable tissue in-growth and endothelizationto occur. Additionally, the first material layer 30, being formed of apolyurethane foam, enables aggressive growth of tissue from the LAA wallinto the tissue growth member 28 at the inside or concave side of themedical device 20. Further, the first material layer 30 provides anexposed shelf 38 on the outer surface 40 around the periphery and distalend portion of the tissue growth member 28, which promotes aggressivefibroblast and tissue growth to further initiate endothelization overthe outer surface 40 of the second material layer 32. It is noted thatthe use of appropriate adhesive materials between the first materiallayer 30 and the next adjacent layer 32A may also serve to fill in thepores of the next adjacent layer 32A and further inhibit possible flowof blood through the tissue growth member 28. Additional layers of ePTFEmay also be included to the second material layer 32 of the tissuegrowth member 28.

With reference to FIGS. 2 and 3, description of the medical device 20and its frame components will now be provided. FIG. 2 depicts the framecomponents in an assembled and fully deployed state and FIG. 3 depictsthe frame components as cut from a flat sheet. As previously set forth,the medical device 20 includes an occluder portion 24 and an anchorportion 26. The occluder portion 24 may include multiple occluder framesegments that may be interconnected to form the occluder portion 24. Theoccluder portion 24 may extend between a first end 44 and a second end46 with face struts 50 and an occluder zig-zag portion 52 therebetween.Further, the occluder portion 24 includes base extensions 48 extendingfrom the first end 44. The base extensions 48 may be coupled to a hub 54via rings 56 with notches defined at an inner diameter in the rings 56.Each base extension 48 may extend from a proximal most portion of theoccluder portion 24 or first end 44, the first end 44 being one end ofeach base extension 48 and face strut 50. Each base extension 48 may besized and configured to be positioned around the hub 54 and held by oneor more rings 56. Each base extension 48, at the first end 44, mayextend to one face strut 50 of the occluder portion 24, the face strut50 extending radially and distally from the first end 44. Each facestrut 50 may include an extension 58 on a back side thereof, theextension 58 having a hook configuration sized and configured to hold aportion of the tissue growth member (not shown). Further, each facestrut 50 extends to a v-extension 60 of the occluder zig-zag portion 52such that distal ends of each v-extension 60 may be coupled to distalends of adjacent v-extensions 60 (side-by-side) to define the occluderzig-zag portion 52. The occluder zig-zag portion 52 may enlarge radiallyand distally from the face struts 50 to a distal end or the second end46 of the occluder portion 24. At the second end 46, the occluderportion 24 may include an occluder eyelet 62 sized configured tohingably couple to the anchor portion 26.

The anchor portion 26 may include multiple anchor frame segments thatmay be interconnected to form the anchor portion 26. The anchor portion26 may extend between a first end 64 and a second end 66 with anchoractuator arms 68 and an anchor zig-zag portion 70 therebetween. Theanchor actuator arms 68 may extend between the first end 64 and theanchor zig-zag portion 70. Each anchor actuator arm 68 may be configuredto couple to a collar arrangement or splined sleeve 72 at the first end64 of the anchor portion 26 such that the anchor actuator arms 68 arecoupled as a unit or together via the splined sleeve 72. The splinedsleeve 72 may be configured to actuate along an axis 74 of the medicaldevice 20 to move the anchor portion 26 between the anchor deployedposition and anchor non-deployed position (not shown), discussed in moredetail hereafter.

With reference now to FIGS. 2, 3, and 3A, the anchor actuator arms 68may also include a flexure portion 76. The flexure portion 76 defines ataper 82 and radius extending along the radial length of the flexureportion 76 toward the anchor zig-zag portion 70 and then widens again atthe anchor zig-zag portion 70. Such taper 82 along the radial length inthe flexure portion 76 facilitates repetitious movement of the anchorportion 26 between the deployed position and the non-deployed positionwhile also maintaining structural integrity of the anchor portion 26,and minimizing the stress and strain in the flexure portion 76 whilefacilitating a tight radius or loop. In one embodiment, the anchoractuator arms 68 may each include a coil (not shown) that may be woundaround a portion of the actuator arm and over the flexure portion 76with the ends of the coil secured to the anchor actuator arm 68. Suchcoil may substantially capture the anchor actuator arm 68 from extendingin undesirable locations in the LAA should there be a facture or breakin the anchor actuator arm 68.

Each flexure portion 76 of the anchor actuator arms 68 may extend toanchor v-extensions 78 such that the proximal ends of each anchorv-extension 78 may be coupled to proximal ends of adjacent anchorv-extensions 78 (similar to the occluder zig-zag portion 52) to form theanchor zig-zag portion 70. At the interconnection of the proximal endsof the anchor v-extensions 78 or the second end 66 of the anchor portion26, such proximal ends define an anchor eyelet 80. The anchor eyelet 80may be sized and configured to hingably couple to a correspondingoccluder eyelet 62 of the occluder portion 24, as shown by dotted lines84 (see FIG. 3).

With respect to FIG. 3A, the anchor struts or anchor v-extensions 78 ofthe anchor zig-zag portion 70 may include one or more hooks 86 or barbsthat may extend at an acute angle 88 from the anchor portion 26 oranchor v-extensions and remote from the occluder portion 24. Such acuteangle 88 may range between about forty-five degrees and about sixtydegrees. Further, the hooks 86 may extend from the anchor v-extensions78 with a predetermined height 90 so as to provide effective engagementwith a tissue wall within the LAA, but not to the extent of piercing allthe way through the tissue wall to cause effusions in the LAA. The hooksalso include a thickness 92 (see FIG. 2). Such thickness 92 may besimilar to the thickness of sheet material from which the famecomponents (i.e., occluder portion 24 and anchor portion 26) of themedical device 20 are cut.

With respect to FIG. 3, the occluder portion 24 and the anchor portion26 are depicted in a pre-formed state subsequent to being laser cut froma flat sheet or sheet material of, for example, super elastic material,such as Nitinol. As such, the occluder portion 24 and the anchor portion26, in the pre-formed state, may be substantially planar and flat, afterwhich, the frame components of the occluder portion 24 and/or the anchorportion 26 may then be heat-set to a desired shape and configuration, asknown to one of ordinary skill in the art, similar to the fully deployedconfiguration (see FIG. 2). Further, as known to one of ordinary skillin the art, other processes may be employed, such as chemical etchingand electro-polishing of the frame components. The occluder portion 24may include ten face struts 50 and ten base extensions 48 with tenoccluder eyelets 62 extending from the occluder zig-zag portion 52.Similarly, the anchor portion 26 may include ten anchor actuator arms 68with ten anchor eyelets 80 extending from the anchor zig-zag portion 70.It should be noted that the occluder portion 24 and anchor portion 26may include more or less frame components, such as the respective facestruts 50 and anchor actuator arms 68, as known to one of ordinary skillin the art. As shown by dotted line 84, occluder eyelets 62 may beconfigured to couple to corresponding anchor eyelets 80 with ahinge-like coupling arrangement. Such may be employed by directlyinterlocking the occluder eyelets 62 with the anchor eyelets 80, asdepicted in FIG. 2.

In another embodiment, the fame components of the occluder portion 24and the anchor portion 26 may be laser cut from tubular material, ratherthan a flat sheet. In this embodiment, the frame components may be lasercut, and then heat set to the desired configuration, similar to thatshown in FIG. 2. Various frame components of the occluder portion 24 andthe anchor portion 26 may need to be modified as readily understood byone of ordinary skill in the art.

With reference to FIG. 3B, in another embodiment, the occluder portion24 and the anchor portion 26 may be hingably coupled together byaligning the occluder eyelets 62 with the anchor eyelets 80 andpositioning an individual interlocking piece 94 (shown in outline)within and through each of the respective aligned eyelets 62, 80. Suchan interlocking piece 94 may be a polymeric filament or the like. Ends96 of the interlocking piece 94 may be heated to form a bulbous shape(not shown) at the ends 96 that, upon cooling, harden and maintain thebulbous shape so as to prevent the respective aligned eyelets fromde-coupling. In this manner, the occluder and anchor eyelets 62, 80 maybe interlocked via the interlocking piece 94 to provide a hingedcoupling arrangement for the anchor portion 26 to pivot relative to theoccluder portion 24 and, more particularly, for the anchor portion 26 topivot about the occluder eyelets 62. In another embodiment, theinterlocking piece 94 may be a metallic rivet press fitted throughaligned eyelets to provide a hinged coupling arrangement.

Now with reference to FIG. 4, a medical device delivery system 100 fordelivering the medical device 20 to, for example, the LAA is provided.The medical device delivery system 100 may include the before-mentioneddelivery system 22, the medical device 20, and a sheath 102. Thedelivery system 22 may include a delivery catheter 104 coupled to ahandle 106 with the medical device 20 operatively coupled to the handle106 at a distal end of the delivery catheter 104. The delivery catheter104 may be sized and configured to be inserted through the sheath 102such that the medical device 20 may be pushed through the sheath 102 tothe distal end thereof. The medical device 20 may be partially exposed,at certain stages of delivery, as depicted. The functionality and detailof the various components of the medical device delivery system 100 willbe described in detail hereafter.

With reference now to FIGS. 5, 5A, and 5B, a distal portion of thedelivery catheter 104 will now be described, FIG. 5A being across-sectional view of the distal portion of the delivery catheter 104along an axis 106 thereof depicted in FIG. 5 and FIG. 5B being anenlarged cross-sectional view of a portion of the same. The deliverycatheter 104 may define a lumen 108 extending longitudinallytherethrough between a proximal end (not shown) and a distal end 110 ofthe delivery catheter 104. In one embodiment, the delivery catheter 104may include a shaft (not shown), a spiral cut portion 112, an innerdistal tube 114, and a collet 116. Such distal portion of the deliverycatheter 104 may include enhanced lateral flexiblity along the region ofthe spiral cut portion 112. That is, the distal portion of the deliverycatheter 104 may be more flexible than portions of the delivery catheter104 more proximal than the spiral cut portion 112. The spiral cutportion 112 may be formed by spirally or helically cutting a slit intothe peripheral structure of the distal portion of the delivery catheter104, as depicted. The inner distal tube 114 may be coupled to thedelivery catheter 104 and within the lumen 108 of the distal portion ofthe delivery catheter 104. The collet 116 may be positioned andthermally coupled to the distal end 110 of the delivery catheter 104 andwithin the inner distal tube 114 with collet fingers 118 extendingdistally therefrom. The collet fingers 118 may be sized and configuredto latch to the hub of the medical device (not shown) with nubs 120 orprotrusions extending from free ends of the collet fingers 118. Thecollet fingers 118 are moveable outward, as indicated by arrows 122, andare biased to an inward position as shown. The collet 116 and colletfingers 118 may be made from a metallic material, such as stainlesssteel or Nitinol, or any other suitable metallic material that canmaintain a biasing force. Such inward biasing of the collet fingers 118will be discussed in further detail hereafter. With respect to theenhanced flexibility of the delivery catheter 104 along the spiral cutportion 112, such enhanced flexibility facilitates the medical device toself-center upon being deployed in the LAA. In other words, the radialstrength of the medical device (not shown) may be greater than thelateral forces of the delivery catheter 104 along the spiral cut portion112 to, thereby, allow the medical device to self-center in the LAA ininstances where the axis 106 of delivery catheter cannot be madeconcentric to the ostium of the LAA during delivery and deployment ofthe medical device.

Now with reference to FIGS. 6A, 6B, and 6C, description of steps thatmay be employed for loading the medical device 20 into the sheath 102will now be provided. For example, the delivery catheter 104 may includea loader 124 sized and configured to facilitate loading the occluderportion 24 of the medical device 20 into the sheath 102 so that thedelivery catheter 104 can push the occluder portion 24 through thesheath 102 to a distal portion thereof. With reference to FIG. 6A, theloader 124 may include a tube portion 126 and a handle portion 128. Theloader 124 may be slideably positioned over the delivery catheter 104such that the delivery catheter 104 extends through a bore definedthrough the loader 124. The loader 124 may be moved over the distal endof the delivery catheter 104 and manually moved or forced over theoccluder portion 24 of the medical device 20 so that occluder portion 24moves to a constricted position enclosed within the tube portion 126.However, prior to moving the loader 124 over the occluder portion 24,the anchor portion should be in a non-deployed position such that anactuator knob and plunger shaft of the handle 106 should be moved to aproximal position, as depicted in FIGS. 8 and 8A. Referring back to FIG.6A, once the loader 124 is moved completely over the occluder portion24, the medical device 20 may then be advanced through the sheath 102.The sheath 102, at this point, has already been advanced through thecirculatory system to the heart with a distal portion of the sheath 102positioned in the LAA (not shown), employing typical techniques known inthe art.

As depicted in FIGS. 6B and 6C, the loader 124 may be inserted into thesheath 102 and, more particularly, a sheath hub 130. The sheath hub 130may be coupled at a proximal end of the sheath 102. The components ofthe sheath hub 130 may include a valve 132 and a sheath fluid port 134.The valve 132 may be a rotating hemostasis valve, such as a Touhy Borstvalve or the like, configured to constrict or limit back-flow of bloodfrom the sheath 102 upon rotation of the valve 132. The sheath fluidport 134 may extend from the sheath hub 130 and may be sized andconfigured to flush or aspirate air from the sheath 102 that may becometrapped upon loading the medical device 20 into the sheath 102. Inanother embodiment, the loader 124 may also include a valve positionedaround the delivery catheter 104 to maintain hemostasis while insertedinto the sheath hub 130.

As set forth, the loader 124 may be mated or inserted into the sheathhub 130 with a snap or click fit via nubs 136 at the distal end of thetube portion 126 and a rib (not shown) within a bore 138 defined in thesheath hub 130. Once the loader 124 is positioned within the sheath hub130, the delivery catheter 104 may be advanced through a lumen definedlongitudinally in the sheath 102 such that the distal end of thedelivery catheter 104 moves to a distal portion of the sheath 102 toexpose a distal tip of the occluder portion 24 of the medical device 20from the distal end of the sheath 102. With this arrangement, the distaltip of the occluder portion 24 may be exposed at the distal end of thesheath 102 and provides, due to the occluder material, a cushioned tip140, without any exposed metal frame members, facilitating an atraumaticentry into the LAA, thereby, reducing the potential of effusions in theLAA.

Referring to FIGS. 7 through 11, deployment and detachment of themedical device 20 in an LAA 5 (shown in outline) relative to thedelivery system 22 will now be described. With respect to FIGS. 7 and 8,upon the physician positioning the distal portion of the sheath 102 inthe LAA 5 with the medical device 20 positioned at the distal portion ofthe sheath 102 with the cushioned tip 140 of the occluder portion 24exposed at the distal end of the sheath 102, the physician mayatraumatically position the distal portion of the sheath 102 to adesired location in the LAA 5. Once the desired location is determined,the physician can deploy the occluder portion 24 of the medical device20. Such may be employed by simply withdrawing the sheath 102 ormanually moving the sheath 102 in a proximal direction. As the sheath102 is withdrawn, the occluder portion 24 self-expands to an occluderdeployed position with the anchor portion 26 maintained in an anchornon-deployed position, as depicted in FIG. 8.

With respect to FIG. 8, a distal portion of the delivery catheter 104coupled to the medical device 20 is shown. The delivery catheter 104 ofthis embodiment is coupled to the medical device 20 with an occluder hubnut 142 and collet 116 arrangement. For example, the distal portion ofthe delivery catheter 104 includes the inner distal tube 114 and anactuator shaft 144. The actuator shaft 144 may include a layered coil,such as a speedometer cable, at a distal end portion thereof, which maybe coupled to an inner distal connector 146 moveable within the collet116. As previously set forth, the collet 116 may include collet fingers118 extending distally from the collet 116. The inner distal connector146 may include threads sized and configured to couple to the occluderhub nut 142 and, more particularly, to a threaded screw hole 148 definedin the occluder hub nut 142. The occluder hub nut 142, at a distal endthereof, may include the splined sleeve 72. As previously set forth, thesplined sleeve 72 may be sized and configured to couple end portions ofeach of the anchor actuator arms 68. In another embodiment, the innerdistal connector 146 and occluder hub nut 142 may be reversed such thatthe inner distal connector 146 includes a nut configuration and theoccluder hub nut 142 includes a screw configuration. In either case, themedical device 20 may be threadably coupled to the delivery catheter104.

With reference to FIG. 8A, one embodiment of the handle 106 is depicted.The handle 106 may include a handle housing 150, an anchor actuatorrelease button 152, a plunger shaft 154, and an actuator knob 156. Thehandle housing 150 may be coupled to a proximal portion of the deliverycatheter 104. The plunger shaft 154 and actuator knob 156 is shown in afirst position that correlates to the anchor portion 26 being in anon-deployed position (see FIG. 8). The plunger shaft 154 and actuatorknob 156 may be moved bi-linearly between a first position and a secondposition while depressing the anchor actuator release button 152. Thefunctions and various components of the handle 106 will become apparentto one of ordinary skill in the art as discussed in further detailhereafter.

As depicted in FIGS. 8 and 8A, the anchor portion 26 of the medicaldevice 20 is in an anchor non-deployed position. The actuator knob 156and plunger shaft 154 are moved to the first position, as indicated byarrow 155 that corresponds to the anchor non-deployed position prior toloading the medical device 20 into the loader 124 and then into thesheath 102 (see FIGS. 6A and 6B). In the anchor non-deployed position,the inner distal connector 146 is threadably coupled to the occluder hubnut 142 and is positioned proximal the hub 54 with the anchor portion 26in a first position or an anchors non-deployed position or, otherwisesaid, an anchors-in position with a portion of the anchor actuator arms68 proximal the hub 54 and within a bore 158 defined in the hub 54.Further, in the anchor non-deployed position, the plunger shaft 154 andknob 156 of the handle 106 may be in a proximal or first position aswell. With this arrangement, a physician may determine the mostfavorable position of the medical device 20 within the LAA 5 with theoccluder portion 24 in the deployed position prior to deploying theanchor portion 26.

Now turning to FIGS. 9 and 9A, the anchor portion 26 of the medicaldevice 20 may be moved to an anchor deployed position or anchor-out oranchor second position once the physician determines the deployedoccluder portion 24 is positioned in the LAA 5 as desired. Such anchordeployed position may be employed by manually moving the actuator knob156 distally, as indicated by arrow 160, while also depressing therelease button 152. In the anchor deployed position, the inner distalconnector 146 and occluder hub nut 142 are also moved distally from thecollet 116 and into the hub 54 or through the hub 54. Such linear distalmovement also moves the anchor actuator arms 68, coupled to the splinedsleeve 72, from a distal portion of the delivery catheter 104, throughand out of the hub 54 to an everted, deployed position or an expandedposition such that the anchor portion 26 unfolds and expands radially bypivoting or rotating at the hinged connection (i.e., at occluder andanchor eyelets 62, 80) between the occluder portion 24 and anchorportion 26. At the anchor deployed position, hooks 86 or tines of theanchor portion 26 are sized and configured to grab tissue and preventmovement so as to effectively anchor the medical device 20 within theLAA 5. Once the anchor portion 26 is deployed, the physician may viewthe medical device 20 through imaging techniques to ensure properpositioning of the medical device 20 in the LAA 5 while also performingstability tests by pulling proximally on the handle 106 to ensure themedical device 20 is effectively engaging the LAA 5. Such imagingtechniques may be enhanced by markers strategically located on themedical device 20 and delivery catheter 104 to provide imaginginformation to the physician. Such markers may be made from a radiopaquematerial, such as platinum, gold, tantalum, or alloys thereof, or anyother suitable radiopaque materials that are biocompatible.

The hooks 86 of the anchor portion 26 may extend both distally andproximally so as to substantially prevent movement of the medical device20 in both the proximal and distal directions relative to the LAA 5. Inone embodiment, the hooks 86 may include an acute angle 88 (FIG. 3A)relative to the axis 74 of the medical device 20 or the struts of theanchor zig-zag portion 70. The hooks 86 are configured to grab and maydig at the tissue of the LAA 5. Such hooks 86 may be sized, oriented,and configured to prevent puncture or piercing of the hooks 86 all theway through the tissue of the LAA 5, but provide effective and evenaggressive engagement with the tissue to provide safe anchoring of themedical device 20 in the LAA 5.

If the physician is dissatisfied with the location or engagement of themedical device in the LAA, the physician may readily disengage theanchor portion 26 from the tissue of the LAA by simply moving theactuator knob 156 in the proximal direction to the first position (FIG.8A), which simultaneously moves the actuator shaft 144 proximally and,thus, pivots the anchor portion 26 to a disengaged or anchornon-deployed position. The physician may then re-position the occluderportion 24 within the LAA 5 and, once satisfied with the location of theoccluder portion 24 in the LAA 5, the physician may readily move theactuator knob 156 forward or a distal direction to pivot and re-engagethe anchor portion 26 with the tissue of the LAA 5. The physician maythen determine again through imaging and stability tests if the medicaldevice 20 is positioned in the LAA 5 in an effective and safe mannerthat satisfies the physician. As can be readily understood, the steps ofre-positioning the occluder portion 24 and re-engaging the anchorportion 26 of the medical device 20 can be repeated until the physicianis satisfied.

Now referring to FIGS. 10, 10A, and 10B, the functions of releasing themedical device 20 will now be described. The medical device 20 may bedetached or released by unscrewing the inner distal connector 146 fromthe screw hole 148 defined in the occluder hub nut 142. Such releasingmay be employed by rotating the actuator knob 156 of the handle 106counter-clockwise several turns, as indicated by arrow 162, until theinner distal connector 146 unwinds from the screw hole 148 of theoccluder hub nut 142. The actuator knob 156 may then be pulledproximally back to the first position, as indicated by arrow 164, whiledepressing the release button 152, which facilitates movement of theinner distal connector 146 in the proximal direction. As the innerdistal connector 146 is moved proximally through or into the collet 116,the collet fingers 118 extending distally from the collet 116 collapseinward since the collet fingers 118 may be biased toward an inwardposition. In other words, prior to the inner distal connector 146 beingunwound, the collet fingers 118 may be held in an outer positionsubstantially concentric with the axis 74 of the medical device 20,which maintains the delivery catheter 104 locked to the medical device20. The collet fingers 118 include outward extending nubs 120 that areheld against an abutment 166 within the hub 54 (also shown in FIG. 9).In this manner, once the inner distal connector 146 is unscrewed fromthe occluder hub nut 142 and moved to a proximal position away from thecollet fingers 118, the collet fingers 118 flexibly collapse with a biasto an inward position to move the nubs 120 away from the abutment 166 inthe hub 54, thereby, unlocking or unlatching the delivery catheter 104from the medical device 20. The delivery catheter 104 may then beremoved from the medical device 20 with the collet fingers 118 collapsedand the nubs 120 moved proximally from the abutment 166 within the hub54 as depicted in FIG. 11.

With respect to FIGS. 2 and 12, a moveable portion that may include aspring 170 is depicted. In one embodiment, the moveable portion mayinclude a spring 170 with a polymeric covering in the form of polymericflaps or occluder flaps 36. Such moveable portion having the spring 170may be sized and configured to close-off the bore 158 of the hub 54 oncethe delivery catheter 104 is released from the medical device 20. Thespring 170 may include a clover configuration or any other suitableconfiguration to effectively close-off the hub 54. The spring 170 maymove between a first biased position (or open first position) and asecond relaxed position (or closed second position). The first biasedposition of the spring 170 (shown in outline form) is depicted in FIG.12, which is the position of the spring 170 with the delivery catheter104 coupled to the hub 54. In one embodiment, the position of thedelivery catheter 104 attached to the hub 54 holds the spring 170 in thebiased or open first position. Once the delivery catheter 104 is removedfrom the hub 54, the spring 170 may automatically move to the closed,second relaxed position (see FIG. 2) with the occluder flaps 36 (seealso FIG. 1) substantially minimizing or eliminating any through hole onthe proximal face and adjacent the hub 54. In the second relaxedposition of the spring 170, the bore 158 defined in the hub 54 issubstantially closed-off with occluder flaps 36, leaving only across-like slit (as depicted by adjacently extending occluder flaps 36in FIG. 1) and substantially eliminating any metal exposed at the hub54. In this manner, the occluder flaps 36, in the closed secondposition, advantageously provides a surface at the proximal face of thedevice without exposed metal at the hub 54 and, further, provides acontiguous surface with the polymeric material of the occluder portionthat closes-off the hub 54.

As previously set forth, the spring 170 may be embedded in the occludermaterial or tissue growth member 28 or attached to an inner occludermaterial surface such that the spring 170 may include various layersand/or folds of, for example, ePTFE, with one or more slits defining theflaps 36 that facilitates interconnection of the delivery catheter 104to the hub 54 when the spring 170 is in the first biased position butthen may substantially close-off the bore 158 defined in the hub 54 whenin the second relaxed position. Such arrangement is advantageous tosubstantially prevent blood flow through the hub 54 or to substantiallyprevent the potential of migrating emboli or thrombus from the hub 54itself once the medical device 20 is positioned in the LAA. In thismanner, the spring 170 facilitates closing-off the through hole of thehub 54 and/or covers any exposed metal at the hub so that emboli orthrombus that may collect on the metal is prevented from escaping fromthe hub. In other words, the flaps 36 provide a substantially impassiblebarrier relative to otherwise potential migrating emboli or thrombus atthe hub 54.

Now referring to FIGS. 13A and 13B, actuation of the release button 152of the handle 106 is depicted. The handle housing 150 defines a hole 172that may extend along a longitudinal axis of the handle housing 150 andmay be sized to hold the plunger shaft 154 to move bi-linearlytherethrough. The handle housing 150 may also define a hollow portion174 therein. The plunger shaft 154 may extend through the handle housing150 and be coupled to components coupled to actuator shaft 144 and theinner distal connector 146 at the distal portion of the deliverycatheter 104 (see FIG. 9). The handle 106 also may include a leaf spring176 configured to bias against the release button 152. The releasebutton 152 may include a button post 178. The leaf spring 176 may becoupled to the button post 178 to bias the release button 152 to anon-depressed position or first position. The plunger shaft 154 may alsoinclude two travel stops 180 fixed thereto. By depressing the releasebutton 152 to a depressed position or second position, the button post178 depresses the leaf spring 176 and moves within a cavity 182. Oncethe button post 178 is moved within the cavity 182, the travel stops 180coupled to the plunger shaft 154 may then freely move distally (and thenback proximally) past the button post 178 a predetermined distancegauged by the travel stops 180 within the hollow portion 174 defined bythe handle housing 150. In this manner, the plunger shaft 154 may movethe predetermined distance which directly corresponds with the distanceor length moved by the actuator shaft 144 and actuation of the anchorportion of the medical device 20 between the anchor non-deployedposition and anchor deployed position (see FIGS. 8 and 9).

Referring back to FIG. 8, in another embodiment, the sheath 102 mayinclude an imaging device 190. The imaging device 190 may be sized andconfigured to be positioned at a distal end of the sheath 102 and mayinclude one or more lines 192 extending from the imaging device 190 andproximally toward the sheath hub 130 (FIG. 5C) for transferring imaginginformation from the imaging device 190 to a computer and a display (notshown), as known to one of ordinary skill in the art, and viewable bythe physician in real-time. The sheath 102, upon being withdrawn fromthe occluder portion 24, being positioned substantially concentric orproximal of the medical device 20, may be at a vantage point andlocation in the left atrium adjacent the LAA to provide detailed imaginginformation otherwise not readily available to the physician. Theimaging device 190 may be an ultrasound imaging device or any othersuitable imaging device known in the art. In another embodiment, animaging device 190 a may be positioned proximal a distal end of thedelivery catheter 104 in a similar manner to that described above. Instill another embodiment, the distal end of the delivery catheter 104and/or sheath 102 may include one or more sensor devices 191. The sensordevices 191 may be configured to sense pressure, flow, and any othercardiac dynamics that may be useful to the physician. In this manner,the sensor devices 191 and/or imaging device 190, 190 a may provideadditional information to assist the physician to accurately positionthe medical device 20 in the LAA 5.

Now with reference to FIGS. 14A and 14B, another embodiment of a medicaldevice 200 coupled to a distal portion of a delivery catheter 202, themedical device 200 (depicted in a simplistic profile view) in apartially deployed position and fully deployed position, respectively,is provided. As in previous embodiments, the medical device 200 mayinclude an occluder portion 204 and an anchor portion 206 that may beseparately deployed. For example, once a sheath 208 is positioned in theLAA (not shown) with the medical device 200 at a distal end portionthereof, the sheath 208 is withdrawn to deploy an occluder portion 204of the medical device 200 or to partially deploy the medical device 200.Once the occluder portion 204 is deployed, then the anchor portion 206may be deployed, to fully deploy the medical device 200.

In this embodiment, the occluder portion 204 is substantially similar tothe previous embodiment, except the tissue growth member 210 is attachedto an outer surface of the frame components of the occluder portion 204.The tissue growth member 210 of this embodiment may include similarlayering of one or more materials as set forth for the tissue growthmember described in detail relative to FIG. 1B. Further, although theanchor portion 206 may be hingably coupled to the occluder portion 204with a hinge arrangement 212 and, in many respects functions similar tothe previous embodiment, the anchor portion 206 of this embodimentincludes multiple separate and distinct anchor frame segments 214, bestshown in FIG. 15.

With reference to FIG. 15, the frame components of the occluder portion204 and the anchor portion 206 are depicted in, for example, a preformedstate subsequent to being laser cut from a flat sheet of super elasticmaterial, such as Nitinol. For simplicity purposes, there is only oneanchor frame segment 214 shown, but in this embodiment, there may befive anchor frame segments 214 to correspond and couple to, for example,occluder frame apertures 216 of the occluder portion 204. As shown, theframe components of the occluder portion 204 may be substantiallysimilar to the frame components of the occluder portion 204 described inthe previous embodiment relative to FIG. 3.

With respect to the anchor frame segments 214, each anchor frame segment214 may extend between a first end 218 and second end 220 with twoactuator arms 222 extending therebetween such that each anchor framesegment 214 may exhibit a “Y” or “V” configuration in the pre-formedstate. Each actuator arm 222 may include an anchor hinge aperture 224 atthe second end 220 and, at the first end 218, the actuator arm 222 maybe coupled to a collar arrangement 226 or splined sleeve, similar tothat of the previous embodiment. With this arrangement, the actuatorarms 222, as depicted in FIGS. 14A and 14B, may pivot about the occluderportion 204 at the hinge arrangement 212. Further, the actuator arms 222may form a loop configuration or loop extension in the anchor deployedposition with the first end 218 of the actuator arms 222 moveable oractuatable through the hub 228 of the medical device 200.

Now with reference to FIGS. 16A, 16B, and 17, another embodiment of amedical device 250 depicted in a partially deployed position (FIG. 16A)and a fully deployed position (FIG. 16B), similar to previousembodiments, is depicted. In this embodiment, the occluder portion 252can be similar to the previous embodiments, but the anchor portion 254may include an anchor zig-zag portion 256 and loop extensions 258 oractuator arms as separate anchor frame components. In this embodiment,the medical device 250 may include a dual hinge arrangement. Forexample, the occluder portion 252 may be hingably coupled to an anchorzig-zag portion 256 with a first hinge arrangement 260 and the anchorzig-zag portion 256 may be hingably coupled to the loop extensions 258with a second hinge arrangement 262. The profile and functionality ofthe medical device 250 may be similar to the previous embodiments,except the loop extensions 258 may take a more direct inward angle fromthe anchor zig-zag portion 256 due to the second hinge arrangement 262therebetween. Similar to the embodiment of FIG. 15, this embodiment mayinclude ten loop extensions 258 or actuator arms, though for simplicitypurposes only two loop extensions 258 (as a single loop extensionsegment) are shown in FIG. 17. It should be noted that the embodimentsof FIGS. 14 and 16 also provide the feature to facilitate a cushion tip(not shown) as depicted in FIG. 7 when constricted in the sheath 264.Further, it should be noted the embodiments depicted and describedrelative to FIGS. 1, 14 and 16 include similar features and structureand, therefore, the descriptions provided in one embodiment may also beapplicable to the other described embodiments.

Now with reference to FIGS. 18 through 20, another embodiment of amedical device 300 and a medical device delivery system 302 formodifying an LAA 5 of the heart that facilitates imaging of the LAA 5with contrast fluid 304 and an imaging device (not shown) is provided.In this embodiment, the structural components and functionality of themedical device 300 and the medical device delivery system 302 may besubstantially similar to any one of the embodiments previouslydescribed. For example, the medical device 300 may include an occluderportion 306 and an anchor portion 308, similar to that described above.

In this embodiment, upon the medical device 300 being positioned withinthe LAA 5 with the anchor portion 308 deployed and engaged with tissueof the LAA 5, the medical device delivery system 302 and the medicaldevice 300 may include a common flow path 310 defined therethrough forinjecting a contrast fluid 304 through a hub 312 of the medical device300 and to a distal side of the medical device 300 and into the LAA 5.One important aspect of this embodiment may be that the occluder portion306 of the medical device includes a substantially non-permeablematerial of, for example, a polymeric material, such as foam and/orePTFE, described in earlier embodiments herein as the tissue growthmember. In one embodiment, the ePTFE may be the material that isnon-permeable. In this manner, a physician can determine whether thecontrast fluid 304 is being substantially maintained within the LAA 5 onthe distal side of the medical device 300 to assess whether the medicaldevice 300 is properly positioned within the LAA 5. Also, the physiciancan determine whether there are gaps between an outer periphery 314 ofthe medical device 300 and the tissue of the LAA 5 by viewing thecontrast fluid 304 dissipating from the distal side of the medicaldevice 300, as discussed in further detail below.

In one embodiment, the occluder portion 306 of the medical device 300may include a polymeric material, such as the before-described foamand/or ePTFE. In another embodiment, the polymeric material may includea bio-agent coated over or impregnated within the polymeric material.Such bio-agent may be configured to enhance tissue growth andendothelization over the proximal side of the occluder portion 306 ofthe medical device 300. In another embodiment, the polymeric materialmay include a coating thereon that may be an anti-thrombotic coating,such as Heprin. In still another embodiment, the occluder portion mayinclude a biological tissue, in addition to or instead of thebefore-described polymeric material. Such biological tissue may be abiological sourced tissue, such as pericardial tissue and/or peritoneumtissue, or any suitable biological tissue that is biocompatible as knownin the art. Further, the biological tissue may be non-permeable, strong,and thin so as to readily be moved with the occluder portion framestructure between collapsed and expanded configurations. Further, thenon-permeable characteristics of the pericardial tissue may function tosubstantially maintain contrast fluid 304 in the LAA 5 upon the medicaldevice being positioned in the LAA. In another embodiment, thebiological tissue may be permeable or include portions with permeablecharacteristics and other portions with non-permeable characteristics.

With reference to FIGS. 18, 18A and 18B, the medical device deliverysystem 302 includes a sheath 316, a delivery catheter 318 coupled to ahandle 320, and the medical device 300 coupled to a distal end of thedelivery catheter 318, similar to that described and depicted relativeto FIG. 4 herein (as well as other embodiments herein). The deliverycatheter 318 extends between a proximal end and a distal end such thatthe proximal end is coupled to the handle 320 and the distal end of thedelivery catheter 318 is coupled to the implantable medical device 300.Further, the delivery catheter 318 defines a lumen 322 extending along alongitudinal length of the delivery catheter 318. The handle 320 mayinclude a fluid port 324 sized and configured to directly communicatewith the lumen 322 of the delivery catheter 318. Also, the deliverycatheter 318 may include an actuator shaft 326 (coupled to the handle320 and actuatable by the actuator knob 321) extending therethrough forcontrolling actuation of the anchor portion 308 of the medical device300. With this arrangement, fluid, such as contrast fluid 304, may beinjected through the fluid port 324 of the handle 320 and directlythrough the lumen 322 of the delivery catheter 318 such that thecontrast fluid 304 may advance toward the medical device 300. Thecontrast fluid 304 may be a radio opaque fluid or dye (or any othersuitable contrast fluid) that is viewable through imaging techniques,such as fluoroscopy or any other suitable imaging technique, as known toone of ordinary skill in the art.

As in previous embodiments, the delivery catheter 318 and the medicaldevice 300 coupled at the distal end thereof may be sized and configuredto be pushed through a sheath lumen 317 defined along a length of thesheath 316. The sheath 316 may also include a sheath fluid port 328sized and configured to inject fluid, such as contrast fluid 304,through the sheath lumen 317 and to exit from the distal end of thesheath 316. Such injection of contrast fluid 304 through the sheathlumen 317 via the sheath fluid port 328 may provide additionalinformation to the physician relative to imaging a proximal side of themedical device 300 upon being positioned in the LAA, discussed furtherherein.

The fluid, such as contrast fluid 304, may be injected through the fluidport 324 of the handle 320, as well as the sheath fluid port 328 of thesheath 316, with an injection device 330. In one embodiment, theinjection device 330 may be a syringe for manual injection through thefluid port 324 of the handle 320 or through the sheath fluid port 328 ofthe sheath 316. In another embodiment, the injection device 330 mayinclude an injection machine that controls the pressure, amount, and/orflow rate of fluid being injected through the fluid port 324 of thehandle 320 (or through the sheath fluid port 328 of the sheath 316), asknown to one of ordinary skill in the art.

Now with reference to FIGS. 19 and 20, fluid, such as contrast fluid304, may flow through the lumen 322 of the delivery catheter 318, asdiscussed above, and through the hub 312 (and components associatedtherewith) of the medical device 300, the medial device 300 beingpositioned in the LAA 5. As the contrast fluid 304 exits the hub 312 ofthe medical device 300, as depicted by arrows 332 in FIG. 19, thecontrast fluid 304 mixes with the blood in the LAA 5 and is viewable viareal-time imaging techniques, such as with a fluoroscopy or the like.Due to the occluder portion 306 having the substantially non-permeablematerial associated therewith, if the medical device 300 is properlypositioned in the LAA 5, the contrast fluid 304 may be substantiallymaintained within the LAA 5, but for general seeping around the outerperiphery 314 of the medical device 300 without an identifiable sourceor gap. In this manner, the physician can readily identify if themedical device is properly positioned within the LAA by viewing thecontrast fluid 304 substantially maintained on a distal side of themedical device. The meaning of substantially maintaining contrast fluid304 in the LAA means substantially containing, sustaining and/orretaining the contrast fluid in the LAA, except for general seepingalong the outer periphery 314.

If there is a gap between the outer periphery 314 of the medical device300 and the tissue of the LAA 5, the physician will readily ascertainand identify such gap due to the contrast fluid 304 moving through alocalized portion from the LAA 5 such that contrast fluid is viewable ina concentrated flow or jet escaping the LAA 5 and moving proximally pastthe outer periphery 314 of the medical device 300. If the physiciandetermines there is a gap, the physician can readily retract the anchorportion 308 and re-position the medical device 300 in the LAA 5 and thendeploy the anchor portion 308 to engage the tissue in the LAA 5, asdiscussed in detail herein. The physician may then inject additionalcontrast fluid 304 through the hub 312 of the medical device 300 todetermine if the medical device 300 is properly positioned. In addition,the physician may also inject contrast fluid 304 through the sheath 316via the sheath fluid port 328, as previously discussed, to view aproximal side of the medical device 300 in the LAA 5, thereby, obtainingadditional information relative to the position of the medical device300 in the LAA 5. Once the physician is satisfied with the position ofthe medical device 300, the delivery catheter 318 may be de-coupled ordetached from the medical device 300, as previously set forth herein.

With respect to FIGS. 20, 20A, and 20B, the flow path (depicted byarrows 310 in FIG. 20) of the contrast fluid 304 flowing from thedelivery catheter 318 and through the hub 312 will now be described. Theflow path 310 extends through the lumen 322 of the delivery catheter 318and surrounds and moves along a length of the actuator shaft 326 and thedelivery catheter 318. Section 20C identified in FIG. 20 may besubstantially similar to that described and depicted in FIG. 18A,depicting the delivery catheter 318 defining the lumen 322 with theactuator shaft 326 positioned therethrough. The flow path 310 continuesto advance along the collet 336 and then outward into a space 334 orchannel defined between the collet fingers 338 (see FIGS. 20 and 20A).The flow path 310 continues advancing between an inner distal connector340 and the delivery catheter 318 and then between the inner distalconnector 340 and the medical device 300 (only the hub 312 is shown), asdepicted in FIGS. 20 and 20A. The hub 312 includes a guide ring 342 thatmay be embedded within the inner diameter or bore 344 defined in the hub312 itself. Such guide ring 342 includes apertures 346 (see FIG. 20B)defined therein through which the flow path 310 extends. Such apertures346 may include an annular space or partial annular configuration orspace. In another embodiment, the inner diameter or bore may include anannular protrusion, instead of the guide ring 342, such that the bore344 between the annular protrusion and the inner distal connector 340may define an annular space through which the flow path 310 extends(instead of the apertures 346). Once the flow path 310 continues throughthe apertures 346 or annular space and past the guide ring 342 orannular protrusion in the bore 344, the flow path 310 continuesadvancing through the bore 344 of the hub 312 and distally over theinner distal connector 340. The inner distal connector 340 may includethreads along an inner diameter thereof to couple to threads on aproximal end of the anchor hub 350. The flow path 310 continuesadvancing through the hub 312 until exiting the hub 312, as depictedwith arrows 332, so that contrast fluid 304 can enter the LAA 5 on thedistal side of the medical device 300, as shown in FIG. 19. With thisarrangement, each of the handle 320, delivery catheter 318 and hub 312of the medical device 300 includes a common, shared, or correspondingflow path 310 that facilitates contrast fluid 304 to exit a distal sideof the medical device 300. As such, a physician may view the medicaldevice 300 positioned in the LAA 5 to determine if the contrast fluid304 is being substantially maintained within the LAA (since the occluderportion includes a non-permeable material), but for minor generalseeping along the outer periphery 314 of the medical device 300contacting the LAA 5. In this manner, the physician can obtainadditional imaging information to ascertain whether the medical device300 is properly positioned in the LAA 5.

Now with reference to FIGS. 21 and 22, another embodiment of a medicaldevice 360 for positioning and securing within the ostium of a leftatrial appendage, is provided. The medical device 360 of this embodimentmay be employed with the previously described delivery systems herein,for example, the medical device delivery system 302 with its sheath 316,delivery catheter 318 and handle 320, described and depicted in FIG. 18.Similar to previous embodiments, the medical device 360 may include anoccluder portion 362 and an anchor portion 364, the occluder portion 362and anchor portion 364 including a frame structure or framework. Suchframe structure may define an occluder frame 366 and an anchor frame 368pivotably coupled to each other. In this embodiment, the occluderportion 362 with its frame structure may include different andadditional structural features than previous embodiments. For example,the occluder portion 362 may include additional conformability with theanatomy as well as the occluder portion 362 may hold structuralcharacteristics that enhance its ease for constricting within thesheath.

As set forth, the medical device 360 may include the anchor portion 364.Similar to previous embodiments, the anchor portion 364 may includemultiple anchor frame segments 370 extending between a first end 372 anda second end 374. The first end 372 may be coupled to an anchor hub 376or secondary hub. The second end 374 may include an anchor aperture 378for pivotably coupling to the occluder portion 362. Such pivotablecoupling or connection may be a hingable coupling that may be formedwith interlocking pieces 371, similar to the interlocking pieces 94described relative to FIG. 3B.

In addition, the anchor frame segments 370 may include tines 380 at adistal position of the second end 374 of the anchor portion 364.Further, the anchor frame segments 370 may extend distally from thesecond end 374 and then extend radially inward, and then extendproximally toward the first end 372 and the anchor hub 376 so that adistal most portion of the anchor portion 364 exhibits a loop typeconfiguration or an arcuate component/configuration, similar to previousembodiments. Such distal most portion of the medical device 360 havingthe arcuate component or configuration so that the distal most portionof the medical device may be atraumatic to tissue within the left atrialappendage.

The occluder portion 362 may include a hub 382 or primary hub definingan axis 384 and may include occluder frame segments 386 and a tissuegrowth member 388. The occluder frame segments 386 may extend from aproximal end 390 to a distal end 392, the proximal end 390 coupled tothe hub 382 and the distal end 392 configured to be coupled to thesecond end 374 of the anchor portion 368. In one embodiment, theproximal end 390 may be pivotably coupled to the hub 382, discussed infurther detail herein. The occluder frame segments 386 may extend in acup-like configuration defining an outer side surface or convexconfiguration and an inner side surface exhibiting a concaveconfiguration. The outer side surface of the occluder frame segments 386may be attached to the tissue growth member 388 also having the cup-likeconfiguration.

The tissue growth member 388 may include one or more layers of tissuegrowth material layers. For example, the one or more layers may includeone or more foam layers and/or one or more ePTFE layers. In oneembodiment, the tissue growth member 388 may include a first layer 394,a second layer 396, and a third layer 398. The first layer 394 may be afoam material, such as polyurethane foam or any other suitable polymericmaterial. The first layer 394 may be attached to the outer side surfaceof the occluder frame segments 386 by stitching or sewing the firstlayer 394 to the occluder frame segments 386. In another embodiment, thefirst layer 394 may be adhesively attached and/or hooked to the occluderframe segments 386. The second layer 396 may be smaller in size than thefirst layer 394 and may be disc shaped. The second layer 396 may be afoam material, similar to the first layer 394, and may be adhesivelyattached to a proximal side and outer surface of the first layer 394.The third layer 398 may be an ePTFE layer or other suitable polymericmaterial that induces tissue growth. The third layer 398 may includemultiple ePTFE layers. The third layer 398 of the tissue growth member388 may be adhesively attached to the outer surface of the first andsecond layers 394, 396 or may be attached employing any other suitableaffixing procedure. Further, the third layer 398 may be larger than boththe first and second layers 394, 396 such that the third layer 398 mayextend more distal than the first layer 394. In one embodiment, thethird layer 398 may extend distal the first layer 394 and distal theoccluder frame segments 386.

With reference to FIG. 23, the occluder frame 366 having occluder framesegments 386 are shown as cut from a flat sheet of material. In thisdepicted as-cut state, the occluder frame segments 386 may be amonolithic seamless structure exhibiting a star-like configuration withthe occluder frame segments 386 extending from a central portion to anouter periphery of the star-like configuration. The proximal end 390 ofeach of the occluder frame segments 386 may be at the central portionand the distal end 392 of each of the occluder frame segments 386 may beat the outer periphery of the star-like configuration. The occluderframe segments 386 may include coupling frame segments 400 andintermediate frame segments 402 (or conforming or stabilizing framesegments), the intermediate frame segments 402 and coupling framesegments 400 extending to the outer periphery in an alternating mannersuch that the intermediate frame segments 402 extend between each of thecoupling frame segments 400. The coupling frame segments 400 may bethicker than the intermediate frame segments 402. That is, the couplingframe segments 400 may include a greater width than the intermediateframe segments 402. The intermediate frame segments 402 interconnect thecoupling frame segments 400 with a v-configuration and may provideadditional conformability of the occluder portion 362 with the anatomyof the left atrial appendage. The intermediate frame segments 402provide additional support and points of contact to push and maintainthe tissue growth member 388 (FIG. 21) against the tissue so that theoccluder portion 362 conforms and stabilizes the tissue growth member388 against tissue in the left atrial appendage.

The coupling frame segments 400, adjacent the proximal end 390 orcentral portion, may include a first opening 404, a second opening 406and a fixture holding piece 408. The first opening 404 may be sized andconfigured to couple to retainer fingers 430 of the hub 382 (FIG. 27),discussed in further detail herein. The second opening 406 may be sizedand configured to stitch the first layer 394 of the tissue growth member388 to the occluder frame segments 386. The fixture holding piece 408may be sized and configured to hold the occluder frame 366 throughvarious frame preparation processes, such as electro-polishing. Once thepreparation processes are complete the fixture holding piece 408 may beremoved.

Further, adjacent the distal end 392 of each of coupling frame segments400, the coupling frame segments 400 may include an occluder aperture410 and a third opening 412. The occluder aperture 410 may be sized andconfigured to couple the occluder frame segments 386 to the anchorportion 364 in a pivotable or hinged manner. The third opening 412 maybe utilized as another opening for stitching the first layer 394 of thetissue growth member 388 (FIG. 22) to the occluder frame segments 386.

Now with reference to FIG. 24, the anchor frame 368 is depicted as-cutfrom sheet material, similar to previous embodiments, having amonolithic seamless structure. As in the previous embodiments, theanchor frame segments 370 of the anchor frame 368 may extend between thefirst end 372 and the second end 374. The first end 372 or first endportion may define the anchor aperture 378 and the second end 374 orsecond end portion may include a hub coupling portion 414. The anchoraperture 378 may be sized and configured to couple to the occluderaperture 410 defined in the occluder frame segments 386 to facilitate apivotable or hinge connection. The hub coupling portion 414 may becoupled to the anchor hub 376 (FIG. 22).

The anchor frame 368 may include an anchor tine portion 416 andextensions 418 extending between the first and second ends 372, 374 todefine the multiple anchor frame segments 386. The extensions 418 mayinclude a flexure portion 420 adjacently extending from the anchor tineportion 416, the extensions 418 continuing to the hub coupling portion414 and first end 372 of the anchor frame 368. The anchor tine portion416 may exhibit a zig-zag arrangement or strut segments 422 havingmultiple v-configurations coupled together. The anchor tine portion 416may extend between the anchor apertures 378 and ends of the extensions418. Further, the anchor tine portion 416 may include one or more tines380 extending from the strut segments 422. In one embodiment, the strutsegments 422 may include tines 380 extending proximally and distally. Inanother embodiment, some of the strut segments 422 may include tines 380extending both proximally and distally with other ones of the strutsegments 422 having tines 380 that only extend proximally toward theanchor aperture 378.

With respect to FIGS. 23 and 24, in one embodiment, the anchor frame 368and occluder frame 366 may be laser cut from a flat sheet of superelastic material, such as Nitinol. The anchor frame 368 and occluderframe 366 may then be positioned with fixtures and heat-set in, forexample, a sand bath to set and form the anchor frame 368 and occluderframe 366 in the shape as depicted in FIG. 22. Upon the anchor frame 368and occluder frame 366 being heat-set, the hub 382 may be secured to theproximal end 390 of the occluder frame segments 386.

With respect to FIGS. 25, 25A, 26, and 26A, the hub 382 or primary hubis provided. The hub 382 may include a hub retainer 424 and a hubportion 434. The hub retainer 424, as depicted in FIGS. 25 and 25A, mayinclude a cylindrical portion 426 defining a retainer bore 428 extendingtherethrough. The cylindrical portion 426 may include retainer fingers430 extending from one end thereof and extending and spaced evenly abouta periphery of the one end of the cylindrical portion 426. The retainerfingers 430 may extend radially from the one end to a free end 432. Suchretainer fingers 430 may be sized and configured to extend through thefirst opening 404 adjacent the proximal end 390 of the occluder framesegments 386.

With respect to FIGS. 26 and 26A, the hub portion 434 may include asomewhat cylindrical outer surface 436 and back-stop 438 in the form ofa head portion, the hub portion 434 defining a hub bore 440 extendingtherethrough. The hub bore 440 may define the axis 384 of the medicaldevice 360 (see also FIG. 21). Further, the hub bore 440 may definestructure sized and configured to interact with the delivery catheter,such as a circumferential recess 442 defined in the hub bore 440.

With respect to FIGS. 25A, 26A and 27, the hub 382 may be assembled andcoupled to the occluder frame segments 386. For example, the retainerfingers 430 may be inserted through the first opening 404 of theoccluder frame segments 386. The cylindrical outer surface 436 of thehub portion 434 may then be inserted and positioned within the retainerbore 428 so that the free end 432 of the retainer fingers 430 abut theback-stop 438 of the hub portion 434, as depicted in FIG. 27, so thatthe occluder frame segments 386 may be secured to the retainer fingers430. The hub retainer 424 and the hub portion 434 may be securedtogether via a weld or adhesive or any other suitable method, such as bywelding a seam between the hub retainer 424 and the hub portion 434. Aspreviously set forth, the retainer fingers 430 of the hub retainer 424may extend through corresponding first openings 404 of the occluderframe segments 386 such that the occluder frame segments 386 may bemoveable, to an extent, over the retainer fingers 430 so that theoccluder frame segments 386 may pivot at the proximal end 390 thereofover the retainer fingers 430. With this arrangement, the occluder framesegments 386 may be pivotably coupled to the hub 382 at the proximal end390 of the occluder frame segments 386. Further, in this manner, theoccluder portion 362 may readily constrict and pivot to an occluderconstricted state within the sheath 316 of the delivery system 302 and,upon the occluder portion 362 being moved out of the sheath 316, theoccluder frame segments 386 may pivot so that the occluder portion 362self-expands to a radially expanded position or occluder deployedposition (see FIG. 18).

Now with reference to FIGS. 28-35, various embodiments of an anchorportion, depicting various tine geometries, sized and configured to becoupled (or operatively coupled) to any one of the occluder portionembodiments set forth herein are provided. As such, any one of theanchor portion embodiments may be employed as the anchor portion to forma medical device, such as depicted in FIGS. 1 and 21, sized andconfigured to implant within the left atrial appendage as describedherein. Several considerations are made relative to tine geometries fora given anchor portion. The different structural characteristics of thevarious tine geometries depicted in the anchor portion embodimentsherein may have preferable tine geometries dependent upon severalfactors relating to, for example, the structural characteristics anddimensions with a particular anchor portion and/or occluder portion ofthe medical device.

One consideration and aspect of tine geometry relates to a tine heightof a given tine or tines of a given anchor portion. For example,increasing the tine height may provide increased anchoring effectivenessbut may also increase the amount of potential tissue damage that mayoccur when the device is pulled upon with enough force to drag the tinesthrough the tissue. Likewise, a decrease in tine height may lower theanchoring effectiveness and may decrease potential tissue damage uponpulling the device before it is detached from the delivery catheter. Ithas been found that a preferable tine height may be dependent uponseveral factors, such as tine angle and spacing between adjacent tines.In one embodiment, a preferable height of a tine may be about 0.032inches and range between about 0.020 inches and about 0.050 inches. Inaddition, tines on struts that may be somewhat bowed may cause the tinesto be more prominent than surrounding features of the device and, thus,may engage the tissue more reliably. Such prominence in the tines mayincrease the effective height of the tines and thus increase anchoringeffectiveness, but may also create inconsistency in situations where thetines contact tissue at a rear wall of the left atrial appendage. Insome embodiments and for consistency purposes, it may be preferable tolimit bowing of the struts.

Another consideration of tine geometry relates to an angle that a giventine extends from a strut of the anchor portion. For example, minimizingan angle of the tines may improve the “grab” of the tines, but may alsotend to hinder releasing the tissue upon retracting the anchor portionif re-positioning the device is desired. It has been found that an angleof the tine, relative to the strut it extends from, between about 25degrees and about 60 degrees may be optimal for engaging tissue as wellas releasing from the tissue. The tine height and spacing betweenadjacent tines may be factors for determining a preferred angle of thetines.

Another factor for tine geometry may include the alignment of the tinesrelative to the struts or axis of the device. For example, tines may beconfigured to align with the axis of the device. That is, tines may beformed to be non-aligned with the struts of the zig-zag pattern of ananchor portion such that the tines are substantially aligned with theaxis of the medical device or such that a given tine may extendsubstantially within a plane defined by a given tine and the axis. Thetines that may be aligned with the axis of the medical device may engagethe tissue more securely, but also may cause more damage to the tissuewhen the device is pulled upon by the delivery catheter. On the otherhand, tines aligned with struts that extend in the before-discussedzig-zag pattern, as depicted in FIGS. 2 and 22 herein, may not bealigned with the axis of the device such that a plane including thestrut and the tines extending from the strut is transverse to the axisof the device. It has been found that tines aligned with the struts ofthe zig-zag pattern may provide sufficient grab for engaging tissue aswell as provide better releasing of tissue so as to minimize anypotential damage to the tissue.

Another consideration for tine geometries may include spacing andquantity of tines on a given strut of an anchor portion. For example,tines on a given strut that may be too close to another tine may loseengagement effectiveness due to load sharing. In other words, tines thatare too close to another strut may result in a “bed of nails” effect. Assuch, adding additional tines in some cases or spacing between tinesbeing too close may not result in higher retention forces. It istherefore desirable to have at least a pre-determined distance for thespacing between adjacent tines along a given strut for the tines toeffectively engage the tissue in the LAA. Dependent upon severalfactors, such as tine angle and tine height, a preferred spacing betweenadjacent tines may be in the range of between about 0.060 inches andabout 0.150 inches or the range between about 0.060 inches and about0.120 inches.

Further, the sharpness of the tine tips may be another considerationrelating to tine geometry. For example, sharper tine tips may yieldbetter tissue engagement with a lower radial force. Anotherconsideration for tine geometries may include tine flexibility, however,due to the height of the tines being minimal, the flexibility of thetines and the struts on which they extend from does not appear to besignificant relative to the compliance of the tissue. In regard to theradial force of the anchor portion against the tissue, it has been foundthat increased radial force provided by the anchor portion and/or theoccluder portion leads to increased retention against pull-out forces.Such increased radial force relative to increased retention appears tobe a somewhat linear relationship.

As can be appreciated, there are several factors that may be consideredrelating to tine geometry. It is desirable for the tines of the anchorportion be reliable to effectively engage the tissue without extendingcompletely through the tissue to potentially cause perfusions as well astine geometries that readily release from the tissue upon retracting theanchor portion from the tissue in the LAA. Various embodiments of tinegeometries associated with an anchor portion will now be described.

With respect to FIGS. 28 and 28A, an anchor portion 450 may be formedfrom a flat sheet of metal, such as Nitinol, by for example, lasercutting, similar to that described in previous embodiments herein.Similar to previous embodiments, this embodiment of the anchor portion450 may extend between a first end 452 and a second end 454 such thatthe first end 452 may couple to an anchor hub 376 (FIG. 22) and thesecond end 454 may couple to a distal end or end portion of an occluderportion 366 (FIG. 22). Further, similar to previous embodiments, theanchor portion 450 may include structure defining anchor struts 456 andanchor actuator arms 458. The anchor struts 456 may extend to formmultiple anchor v-extensions 460 to define an anchor zig-zag portion462. The anchor actuator arms 458 may extend from ends of the anchorv-extensions 460 to the first end 452 of the anchor portion 450.Further, the anchor actuator arms 458 may define a flexure portion 464that may extend with a radius from the anchor v-extensions 460 and maytaper along such radius. The flexure portion 464 may include structuralcharacteristics to facilitate actuating the anchor portion 450 between aretracted position and the deployed position, as set forth in previousembodiments. Further, the anchor portion 450 may define one or moreapertures 466 formed in at least some of the anchor struts 456 of theanchor v-extensions 460. For example, at the second end of the anchorportion or end of the v-extension, one of the apertures may be employedas a coupling aperture 468 or an anchor eyelet sized and configured tocouple to the occluder portion similar to that depicted in FIG. 3B.Further, for example, the one or more apertures 466 may be positionedalong a portion or mid-portion of one of the anchor struts 456 so as tobe sized and configured to receive a marker (not shown). The one or moreapertures 466 sized to receive a marker may be included along everyother anchor strut along the anchor zig-zag portion 462 of the anchorportion 450.

In this embodiment, the anchor portion 450 may include anchor hooks 470or tines extending along the anchor struts 456 of a given anchorv-extension 460. For example, in a given anchor v-extension 460 of theanchor struts 456, the anchor v-extension 460 may extend with a firststrut 472 and a second strut 474. Along the first strut 472, the firststrut may define one of the apertures 466 and the second strut 474 mayextend continuously without an aperture. The first strut 472 may definemultiple anchor hooks 470 or otherwise referenced as tines. Some of theanchor hooks 470 of the first strut 472 may be oriented to extendproximally and some of the anchor hooks 470 may be oriented to extenddistally. The second strut 474 may also define multiple anchor hooks470. Such anchor hooks 470 of the second strut 474 may be oriented toextend proximally such that no anchor hooks extend distally along thesecond strut 474.

In one embodiment, the anchor hooks 470 may extend relative to theanchor strut 456 at a first acute angle 476 and a second acute angle478. For example, the anchor hooks 470 may extend from a base 480 to amid portion to define the first acute angle 476. At the mid portion ormid-height of the anchor hooks 470, the anchor hooks 470 may transitionto the second acute angle 478 to further extend toward a tip 482 or endof the anchor hooks 470, the first acute angle 476 being greater thanthe second acute angle 478. In this manner, the anchor hooks 470 may beoriented to extend proximally and/or distally and then be furtheroriented to extend more proximally and/or more distally so as to exhibita dual angled hook. In one embodiment, the first acute angle 476 may beabout 70 degrees or within the range of about 45 degrees to about 75degrees. The second acute angle 478 may be about 25 degrees or withinthe range to about 20 degrees to about 60 degrees.

In one embodiment, in a given anchor v-extension 460, the first strut472 may include three anchor hooks 470 that extend proximally and twoanchor hooks 470 that extend distally. The second strut 474 may includefour anchor hooks 470 that extend proximally. The aperture 466 sized forreceiving a marker (not shown), as set forth above, may include oneanchor hook 470 extending proximally at one side of the structuredefining the aperture 466 and another anchor hook 470 extending distallyat another side of the structure defining the aperture 466 such that theaperture 466 defines a transition between anchor hooks 470 extendingproximally and distally. From this transition, the anchor hooks 470extending proximally may be substantially evenly spaced relative to eachother along the first strut 472. The anchor hooks 470 extending distallymay include a similar spacing or include a larger spacing as the anchorhooks 470 that extend proximally. Along the second strut 474, the anchorhooks 470 that extend proximally may be substantially evenly spacedrelative to each other. The spacing between anchor hooks 470 may besized and configured such that each anchor hook 470 may effectivelyengage tissue without interfering with adjacently positioned anchorhooks 470. As previously set forth, spacing of adjacent hooks on a givenstrut that are too close may result in load sharing and may lose theirindividual engagement or anchoring effectiveness. For example, spacing486 between adjacently extending hooks may be about 0.065 inches or maybe in the range of about 0.06 inches to about 0.12 inches.

The anchor hooks 470 that extend proximally and distally may include acommon height 484 relative to the first or second strut 472, 474, theheight 484 defined from the base 480 to the tip 482. Such height 484 maybe a predetermined height sized to facilitate engagement, or evenaggressive engagement, of the tissue in the LAA, but a height sized tonot puncture all the way through the tissue at or adjacent the ostium ofthe LAA. For example, the height 484 may be about 0.032 inches or withinthe range of about 0.020 inches and about 0.050 inches. Further, thedepth or thickness 92 (FIG. 2) of each anchor hook 470 may be defined bythe thickness of the flat sheet from which the anchor portion 450 iscut. As such, the tip 482 of the anchor hooks 470 may define an edge,the edge defined by the thickness of the sheet material. In oneembodiment, the sheet material employed may be sized such that the tipof the anchor hooks defines a point. In this manner, the thickness ofthe sheet material employed for cutting the anchor portion 470 maydirectly correlate with whether the tip defines an edge or resemblesmore a point. Other factors that may be effective to reduce an edge to apoint may include the manufacturing processes of abrasive blastingand/or electropolishing.

With respect to FIG. 29, another embodiment of an anchor portion 490with anchor hooks 492 extending from anchor struts 494 of the anchorportion 490 is provided. This embodiment may be similar to the previousembodiment, except in this embodiment first and second struts 496, 498of the anchor v-extension 500 may define less anchor hooks 492 than theprevious embodiment. For example, the first strut 496 may definemultiple anchor hooks 492, such as two anchor hooks that extendproximally and one anchor hook that extends distally. Further, thesecond strut 498 may include three anchor hooks 492 that extendproximally. The anchor hooks 492 of the second strut 498 may be evenlyspaced relative to each other so as to define a spacing 508. The spacing508 of the anchor hooks 492 that extend proximally of both the first andsecond struts 496, 498 may include a substantially common spacing 508between the anchor hooks 492. For example, the spacing 508 of adjacentlyextending anchor hooks 492 of this embodiment may be about 0.100 inchesor range between about 0.060 inches and about 0.120 inches. In addition,the anchor hooks 492 may include a height 509, the height 509 beingabout 0.032 inches and include similar ranges as set forth in theprevious embodiment. Further, similar to the previous embodiment, eachof the anchor hooks 492 may extend proximally or distally with a firstacute angle 502 and a second acute angle 504 to exhibit a dual angledhook such that the first acute angle 502 may be greater than the secondacute angle 504. Such first and second acute angles 502, 504 may includesimilar angle ranges as set forth in the previous embodiment. As in theprevious embodiment, at the aperture 506 sized for a marker defined inthe first strut 496, only one anchor may extend from the structuredefining such aperture 506, rather than two anchor hooks as set forth inthe previous embodiment.

With respect to FIG. 30, another embodiment of an anchor portion 510with anchor hooks 512 extending from anchor struts 514 of the anchorportion 510 is provided. In this embodiment, the anchor hooks 512 mayextend along a first strut 516 and a second strut 518 of a given anchorv-extension 520. Along the first strut 516, the anchor hooks 512 mayextend both proximally and distally. For example, the first strut 516may include two anchor hooks 512 extending proximally and two anchorhooks 512 that extend distally. The two anchor hooks 512 extendingproximally may include a spacing 526 which may be common orsubstantially similar to the spacing between the two anchor hooks 512that extend distally. Such spacing 526 may be about 0.100 inches and mayrange between about 0.060 inches and about 0.120 inches. Further, thefirst strut 516 includes structure defining an aperture 522 such thatone anchor hook extends proximally from the structure that defines theaperture 522 and another anchor hook extends distally from the structurethat defines the aperture 522. The second strut 518 may include threeanchor hooks 512 extending proximally such that each of the three anchorhooks 512 include a substantially common spacing relative to adjacentlyextending anchor hooks 512. Similar to other embodiments set forthherein, each of the anchor hooks 512 may define a single acute angle 524relative to and extending from the anchor strut from which the anchorhook 512 extends from. Such single acute angle 524 of a given anchorhook 512 may be about 30 degrees and may extend in the range of about 25degrees to about 60 degrees. Further, a height 528 of the anchor hooks512 may be about 0.032 inches and may range between about 0.020 inchesand about 0.050 inches.

In another embodiment, as depicted in FIG. 31 and similar to theprevious embodiment of FIG. 30, an anchor portion 530 with first andsecond struts 532, 534 may include additional anchor hooks 536 alongeach of the first and second struts 532, 534 of anchor v-extensions 538of the anchor portion, the anchor hooks 536 having a similar angle andheight with similar ranges as the previous embodiment. For example, thefirst strut 532 may include three anchor hooks 536 extending proximallyand two anchor hooks 536 extending distally. The second strut 534 mayinclude four anchor hooks 536 extending proximally without any anchorhooks that extend distally. Further, a spacing 539 between proximallyextending anchor hooks 536 may be common or substantially similar withthe spacing between distally extending anchor hooks 536. For example,the spacing 539 between adjacent anchor hooks 536 that extend in commondirections may be about 0.073 inches or range between about 0.060 inchesand about 0.120 inches.

Further, in another embodiment, as depicted in FIG. 32 and similar tothe embodiment of FIG. 30, an anchor portion 540 with first and secondstruts 542, 544 may include less anchor hooks 546 extending from anchorv-extensions 548 of the anchor portion 540. For example, the first strut542 may include three anchor hooks 546, two anchor hooks extendingproximally and one anchor hook extending distally. The second strut 544may include two anchor hooks 546 extending proximally without any anchorhooks extending distally. Further, the anchor hooks 546 may define aheight and angle similar to the previous embodiment with similar ranges,but a spacing 549 defined between the anchor hooks 546 may be differentthan the previous embodiments. For example, the spacing 549 betweenproximally extending anchor hooks 546 may be about 0.120 inches orbetween about 0.100 inches and about 0.150 inches.

In still another embodiment, as depicted in FIG. 33, an anchor portion550 with anchor hooks 552 extending from first and second struts 554,556 of anchor v-extensions 558 of the anchor portion 550 may be smallerin height than that depicted in previous anchor hook embodiments. Forexample, the anchor hooks 552 may define a height 559 of about 0.020inches and a range of about 0.015 inches to about 0.030 inches. Further,a spacing 557 between commonly extending adjacent anchor hooks 552 maybe about 0.073 inches and range between about 0.060 inches and about0.120 inches. The anchor hooks, similar to previous embodiments, maydefine an acute angle of about 30 degrees or be in the range of about 25degrees and about 60 degrees.

With respect to FIG. 34, in another embodiment, an anchor portion 560may include first and second struts 562, 564 with minimal anchor hooks566 extending from anchor v-extensions 568 of the anchor portion 560.For example, the first strut 562 may include a single anchor hook 566extending proximally and a single anchor hook 566 extending distally.The second strut 564 may include a single anchor hook 566 extendingproximally therefrom. Further, the anchor hooks 566 may extend with anacute angle 570. The acute angle 570 may be about 45 degrees or in therange of about 25 degrees to about 60 degrees. The anchor hooks 566 mayextend to a point 572 or an edge at a free end thereof to define aheight 574 relative to the corresponding first strut 562 or the secondstrut 564. For example, the height 574 of the anchor hooks 566 may beabout 0.050 inches. In comparison to previous embodiments, the height574 and angle 570 of the anchor hooks 566 may be more prominent toanchor hooks of previous embodiments, but may also include a fewernumber of anchor hooks 566. In another embodiment, the height may beabout 0.032 inches and range between about 0.020 inches and about 0.060inches.

With respect to FIG. 35, another embodiment of an anchor portion 580 isprovided. In this embodiment, the anchor portion 580 may be cut from aflat sheet of, for example, Nitinol in a radial arrangement or radialpattern, similar to the occluder portion 366 depicted in FIG. 23. Theanchor portion being cut in the radial arrangement may be heat-set to aformed shape similar to the anchor portions of previous embodiments,depicted for example in FIGS. 2 and 22. Upon being heat-set and formedas desired, the anchor portion 580 may extend between a first end 582and a second end 584. The first end 582 may couple to an anchor hub 376(FIG. 22) and the second end 584 may couple to a distal end or endportion of an occluder portion 366 (FIG. 22), similar to previousembodiments. The anchor portion 580 may define anchor actuator arms 586extending from ends of anchor v-extensions 588, the anchor v-extensions588 continuously extending to define an anchor zig-zag portion 590. Eachof the anchor v-extensions 588 may define a first strut 592 and a secondstrut 594 extending to exhibit a v-configuration. As in previousembodiments, the first and second struts 592, 594 may include anchorhooks 596 or tines extending therefrom. In this embodiment, the firststrut 592 may include two anchor hooks 596 and the second strut 594 mayinclude one anchor hook 596, similar to the previous embodiment depictedin FIG. 34. Such first and second struts 592, 594 may include additionalanchor hooks 596 or less or any one of the anchor hook variations andstructural characteristics of the tine geometries as set forth in anyone of the anchor portion embodiments described herein. In other words,any one of the anchor portion embodiments described herein may be cutfrom a flat sheet in a radial arrangement or radial pattern, similar tothat set forth in FIG. 35.

Now with reference to FIGS. 36 and 37, another embodiment of a medicaldevice 600, similar to that described and depicted relative to FIGS. 21and 22, except in this embodiment the occluder portion may includealternate occluder materials. As in previous embodiments, the medicaldevice 600 of this embodiment may include an anchor portion 602 and anoccluder portion 604. The anchor portion 602 may be formed from any oneof the anchor portion embodiments cut from, for example, a flat sheet asset forth herein to a radially extending position, as depicted in FIG.36, through a heat-setting process as known to one of ordinary skill inthe art. Further, as in previous embodiments, a first end 606 of theanchor portion 602 may be coupled to an anchor hub 610 and a second end608 of the anchor portion 602 may be hingeably or pivotably coupled to adistal end 612 of the occluder portion 604 with a proximal end 614 ofthe occluder portion 604 being coupled to a hub 616 with a first part618 and a second part 620. With this arrangement, the anchor portion 602may be movable between retracted and deployed positions with the anchorhub 610 being moveable along an axis 622 between respective proximal anddistal positions while the occluder portion is in an expanded position,as described herein.

In this embodiment, the occluder portion 604 may include an occluderframe portion 624 and a tissue growth member 626. The tissue growthmember 626 may also be referenced as an occluder material portion or apolymeric material portion. The occluder frame portion 624 may also beformed from any one of the occluder frame embodiments cut from a flatsheet of, for example, Nitinol, as set forth herein to a radiallyextending position, as depicted in FIG. 36, through a heat-settingprocess. In another embodiment, the occluder frame portion and/or theanchor portion may be cut from tubular stock, rather than from a flatsheet, and then may be formed into the radially extending positions, asdepicted in FIG. 36.

With reference to FIGS. 36 and 37A, in one embodiment, the tissue growthmember 626 may include multiple layers and portions. For example, thetissue growth member 626 may include an inner portion 628 and an outerportion 630 with a middle portion 632 positioned therebetween. Suchtissue growth member 626 may include similar structural characteristicsto that described relative to FIG. 22, such as, being impermeable orimpervious so as to not allow blood to flow through the tissue growthmember. In one embodiment, the inner portion 628 may be positioned sothat an inner surface 634 of the inner portion 628 extends over anddirectly contacts an outer surface 636 of the occluder frame portion 624with at least one layer of a polymeric material, such as a woven ornon-woven material. With this arrangement, the inner portion 628 may beadhesively attached and/or stitched with filaments to the outer surface636 of struts 638 of the occluder frame portion 624. Further, in thisembodiment, the inner portion 628 may be formed with one or more layersof a polymeric material. The polymeric material may include one or morefilaments that may be a knitted, weaved, or braided fabric orcombinations thereof so as to provide a regular or substantiallyconsistent pattern to form, for example, a mesh material. In anotherembodiment, the polymeric material may include one or more filamentsformed in a random or arbitrary pattern. In another embodiment, thepolymeric material may be made from any suitable medical grade polymericmaterial, such as polyester, polypropylene, or polyethylene, or anyother medical grade polymeric material, or the like.

In another embodiment, the inner portion 628 may be a non-woven fabric.The non-woven fabric may be formed of polymeric filaments. For example,the non-woven fabric may be formed with random fibers that may beadhered together with various processes, such as heat pressing or withsolvents as known by one of ordinary skill in the art, or any othersuitable process for forming a non-woven fabric.

The middle portion 632 may be sized and configured to be positionedsymmetrically along the axis 622 and over a central portion of the innerportion 628 and adjacent the hub 616 of the occluder frame portion 624.The middle portion 632 of the tissue growth member 626 may serve as areinforcement layer. Such middle portion 632 may be desirable due to theincreased stresses and tension resulting from pulling and constrictingthe medical device 600 within the sheath 102 of the medical devicedelivery system 100 (FIG. 4), the stresses over the medical device 600being optimal adjacent the hub 61 of the occluder portion 604. Themiddle portion 632 may be disc shaped and may extend with less surfacearea than the inner and outer portions 628, 630 of the tissue growthmember 626. The middle portion 632 may be a polymeric material, such asa woven or non-woven fabric material described herein or any othersuitable polymeric material that may serve as a reinforcement layer. Assuch, the middle portion 632 may be formed of a similar or the samematerial as the inner portion 628. Further, the middle portion 632 maybe adhesively attached to an outer surface of the inner portion 628 orstitched thereto with filaments.

The outer portion 630 of the tissue growth member 626 may be positionedover the outer surface or proximal side of the middle portion 632 andinner portion 628. The outer portion 630 may be formed with successivelayering of polymeric materials each of which may be adhesively attachedover the other. As in previous embodiments, the outer portion 630 of thetissue growth member 626 may be formed of multiple polymeric layers,such as ePTFE, defining, for example, a first layer 640, a second layer642, and a third layer 644. In another embodiment, additional or lesssuccessive layering may be employed to form the outer portion 630. Itshould be noted that the tensile strength of some polymeric materials,such as ePTFE, may be strongest in a first direction and weakest in adirection ninety degrees out-of-phase or orthogonal relative to thefirst direction. As such, the successive layering of adjacent layers ofthe outer portion 630 may be transverse or out-of-phase to each otherrelative to their respective strongest direction of tensile strength. Inthis manner, the multiple layers of the outer portion 630 may besuccessively or consecutively attached to each other and formed tobolster the strength of the outer portion 630.

With respect to FIG. 37A, in another embodiment, the tissue growthmember 626 may include a hydrophilic coating 652, represented by adashed line. The hydrophilic coating 652 may be sized and configured topromote wettability of the tissue growth member 626 for purposes ofimaging the device as well as act as a lubricant to minimize frictionbetween the tissue growth member and the inner surface of the sheath 102(see FIG. 4) as the device is delivered and advanced through the sheath102, as described herein. Such hydrophilic coating 652 may be coatedover the exposed portions of the tissue growth member 626 or may becoated over the outer surface of the outer portion 630 of the tissuegrowth member 626. The hydrophilic coating 652 may sprayed over portionsof the tissue growth member 626 or the tissue growth member 626 may bedipped into a hydrophilic solution such that the hydrophilic solutionmay be integrated within the crevices of the tissue growth member 626 aswell as cover the outer surfaces of the tissue growth member 626. Thehydrophilic coating 652 of the tissue growth member may be any suitablemedical grade hydrophilic coating material, as known to one of ordinaryskill in the art.

With respect to FIGS. 36 and 37, the outer portion 630 may define adistal end portion 646 that extends further distally then a distal end648 of the inner portion 628 of the tissue growth member 626. As such,the distal end portion 646 of the outer portion 630 may extend radiallyin the form of a ring without contacting the inner portion 628 of thetissue growth member 626. In another embodiment, the outer portion 630and the inner portion 628 may extend distally a substantially equalamount. In still another embodiment, the inner portion 628 may define adistal end portion that extends further distally beyond a distal end ofthe outer portion, similar to that depicted in FIG. 1A.

Upon the medical device 600 being implanted in the LAA, the innerportion 628 of the tissue growth member 626 may face and be exposed tothe LAA and the outer portion 630 of the tissue growth member 626 mayface and be exposed to the left atrium of the heart. As set forth, theinner portion 628 may be formed of a polymeric material, such as a wovenor non-woven fabric or the like. The woven or non-woven fabric mayinclude structural characteristics configured to aggressively promoteand enhance tissue growth within and over the polymeric layer. The outerportion 630, also being formed of a polymeric material such as ePTFE,may include structural characteristics to promote the formation of asmooth endothelization layer over the proximal side or outer surface ofthe tissue growth member 626. In this manner, the medical device 600 maybe implanted to permanently occlude the LAA.

While the invention may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the invention is not intended tobe limited to the particular forms disclosed. Rather, the inventionincludes incorporating any portion of one embodiment with anotherembodiment, all modifications, equivalents, and alternatives fallingwithin the spirit and scope of the invention as defined by the followingappended claims.

What is claimed is:
 1. A medical device for implantation in a leftatrial appendage of a heart, the medical device comprising: an occluderportion having a hub and defining an axis, the occluder portionextending between a proximal end coupled to the hub and a distal enddefining an occluder eyelet adjacent thereto; and an anchor portionextending between a first end and a second end, the first end coupled toan anchor hub and the second end defining an anchor eyelet adjacentthereto and hingeably coupled to the occluder eyelet; wherein the anchorhub is moveable along the axis to move the anchor portion between aretracted position and a deployed position upon the occluder portionbeing in an expanded position.
 2. The medical device of claim 1, whereinthe anchor portion extends with anchor frame segments, the anchor framesegments including anchoring tines extending therefrom.
 3. The medicaldevice of claim 2, wherein the anchoring tines extend with an acuteangle relative to the anchor frame segments, the acute angle having arange between about 25 degrees and about 60 degrees.
 4. The medicaldevice of claim 2, wherein the anchoring tines extend with a heightrelative to the anchor frame segments, the height having a range betweenabout 0.020 inches and about 0.050 inches.
 5. The medical device ofclaim 2, wherein the anchoring tines extending from a single strut arespaced a distance from adjacent tines within a range between about 0.060inches and 0.015 inches.
 6. The medical device of claim 1, wherein theanchor frame segments comprise anchoring tines aligned with andextending from struts defining the anchor frame segments, the strutsbeing non-aligned relative to the axis.
 7. A medical device forimplantation in a left atrial appendage of a heart, the medical devicecomprising: a framework having a proximal end and a distal end anddefining an axis, the framework extending between a primary hub and asecondary hub, the primary hub and the secondary hub aligned along theaxis of the framework, the proximal end of the framework coupled to theprimary hub, the framework extending radially outward and distally fromthe primary hub and extending radially inward and proximally toward thesecondary hub such that the secondary hub is positioned proximal thedistal end of the framework.
 8. The medical device of claim 7, whereinthe framework comprises anchoring tines extending therefrom.
 9. Themedical device of claim 8, wherein the anchoring tines extend with anacute angle relative to struts of the framework, the acute angle havinga range between about 25 degrees and about 60 degrees.
 10. The medicaldevice of claim 8, wherein the anchoring tines extend with a heightrelative to struts of the framework, the height having a range betweenabout 0.020 inches and about 0.050 inches.
 11. The medical device ofclaim 8, wherein the anchoring tines extending from a given strut of theframework are spaced a distance from adjacent tines within a rangebetween about 0.060 inches and 0.015 inches.
 12. The medical device ofclaim 7, wherein the framework comprises anchoring tines aligned withand extending from struts of the framework, the struts being non-alignedrelative to the axis.
 13. The medical device of claim 7, wherein theframework comprises occluder frame segments and anchor frame segments,the anchor frame segments hingeably coupled to the occluder framesegments.
 14. The medical device of claim 13, wherein the anchor framesegments are moveable between a retracted position and a deployedposition upon the occluder frame segments being in an expanded position.15. The medical device of claim 7, wherein the framework comprises atissue growth member positioned over at least a proximal side of theframework.
 16. The medical device of claim 7, wherein the frameworkcomprises a tissue growth member including at least one of a fabricmaterial and ePTFE.
 17. The medical device of claim 16, wherein thetissue growth member comprises a hydrophilic coating.
 18. A method foroccluding a left atrial appendage, the method comprising: positioning aframework within the left atrial appendage, the framework having aproximal end and a distal end and defining an axis, the frameworkextending between a primary hub and a secondary hub, the primary hub andthe secondary hub aligned along the axis of the framework, the proximalend of the framework coupled to the primary hub, the framework extendingradially outward and distally from the primary hub and extendingradially inward and proximally toward the secondary hub such that thesecondary hub is positioned proximal the distal end of the framework.19. The method according to claim 18, further comprising securing theframework to tissue within the left atrial appendage with anchoringtines extending from anchor frame segments of the framework.
 20. Themethod according to claim 18, further comprising pivoting anchor framesegments of the framework between a retracted position and a deployedposition.